MELANOMA COMMITTEE Chair: Vernon Sondak, M.D. Vice-Chair: Lawrence Flaherty, M.D. Statisticians: PY Liu, Ph.D. Danni S. Daniels, M.S. Dori Rector, M.S. Data Coordinator: Jamie Straw, B.A. Protocol Coordinator: Dana Sparks Cancer Control Liaison: Vernon Sondak, M.D. Medical Oncologist: Lawrence Flaherty, M.D. Melanoma Biology: Jeffrey Trent, Ph.D. Pathologist: Ralph Tuthill, M.D. Radiotherapist: Nancy Boutin, M.D. Surgeon: William R. Jewell, M.D. Data Manager: Debbie Halk, R.N. Al}ril 13-15, 1992 SOUTIIWEST ONCOLOGY GROUP MELANOMA I
Transcript
MELANOMA COMMITTEE
Chair: Vernon Sondak, M.D.
Vice-Chair: Lawrence Flaherty, M.D.
Statisticians: PY Liu, Ph.D.Danni S. Daniels, M.S.Dori Rector, M.S.
Data Coordinator: Jamie Straw, B.A.
Protocol Coordinator: Dana Sparks
Cancer Control Liaison: Vernon Sondak, M.D.
Medical Oncologist: Lawrence Flaherty, M.D.
Melanoma Biology: Jeffrey Trent, Ph.D.
Pathologist: Ralph Tuthill, M.D.
Radiotherapist: Nancy Boutin, M.D.
Surgeon: William R. Jewell, M.D.
Data Manager: Debbie Halk, R.N.
Al}ril 13-15, 1992 SOUTIIWEST ONCOLOGY GROUP MELANOMA I
Note: Patients with primary tumors on the head, neck, or distal extremities will receive only 2 cmexcision margins,
Objectives distal extremity vs head and neck; and (3) alcera-To determine the safest excision margins around tion of the primary tumor: yes vs no.the primary melanoma.
Accrual GoalsTo evaluate the management of the regional lymph About 775 patients will be required for this prate-nodes (immediate vs delayed lymphadenectomy), col. If the overall evaluability for the study is 90%,
about 861 case entries will be required.To compare different histopathological criteria Fortheir relative value in predicting the patient’s clin- Summary Statementical course and the risk of local recurrence. The following summary is based on a report pro-
Patient Population vided by the Intergroup Melanoma Committee with
Patients must have clinical Stage I cutaneous mal- patient accrual through July, 1991.
ignant melanoma measuring I to 4 mm thick and At the end of July 1991, 784 patients had beenlocated on the trunk, proximal or distal extremities, registered. The Southwest Oncology Group con-head or neck Subungual melanomas are eligible tributed 93 patients (I 1.9%) of the total. On-studyas long as they can be treated with a digital ampu- and pathologic data are presented in the Patienttation. Patients with lentigo maligna melanoma, Characteristics tables. Percentages are based on themelanomas o£ mucous membranes, metastases, ormelanomas with significant regression, or cervical
column totals.
lymphatic drainage to >2 major nodal bases tire The major surgical toxicities which have been re-not eligible, ported are prolonged drainage (19.4%), wound
Patients may not have had previous chemotherapy, separation (6.3%), infection (9.7%), lymphedema
immunotherapy, radiation therapy, or adjuvant (4.6%), and thrombophlebitis (0.3%). These
treatment, centages represent all patients evaluated for toxic-ity.
Stratification/Descriptive FactorsPatients tire stratified by (1) tmnor thickness: 1.00 This study was closed to trunk, proximal and distal- 2.00 mm vs 2.0l - 3.00 mm vs 3.01 - 4.00 ram; (2) extremity melanomas on November 15, 1990 by thetumor primary site: trunk vs proximal extremity vs Intergroup Melanoma Committee. The Southwest
6 MELANOMA 8393]111 SOUTItWEST ONCOLOGY GROUP April 13-15, 1992
Registration by Institution
TOTAL TOTALINSTITUTION REG INSTITUTION REG
Ohio State U 24 Fresno Comm Hospital/Davis, U of CAScott &White/TX A&M 13 Galveston, U of TXKansas, lJ of 8 Good Samaritan ttosp/Puget SoundHenry Ford tlosp 7 Harrington/TexasTech/San Antonio, I1 of TXSpartanburg CCOP 7 Kansas City CCOPArkansas, U of 5 Oklahoma, U ofBAMC/WHMC 4 Oregon Hlth Sci UnivWichita CCOP 4 Ozarks Reg CCOPllawaii, U of 2 So Alabama, U ofTtfiane U 2 St Louis l,)niversityAllegheny CCOP I St Luke’s Hospital/Arizona, U ofCentral WA llospital/Puget Sound I Universily HospitalCleveland Clinic I Utah, U ofColumbia River CCOP I
Totals (27 institutiotxs) 93
Patient Characteristics*AS REPORTFD BY TIlE INTERGROUP MELANOMA COMMITTEE
TRUNK OR PROXIMAL EXTREMITIES
(Data as of 28 AUG 9l)
2 cm margin + node 4 em margin + node2 cm margin dissec 4 cm margin dissec(n- 117) (n = i27) (n ~: 116) (n = 126)
* Discrepancies in totals are due to missing information.
8 MELANOMA 8393/111 SOUTHWEST ONCOLOGY GROUP April 13-15, 1992
SWOG 8913 Phase II
Evaluation of Merbarone in Disseminated Malignant Melanoma
Study Coordinators: Date Activated:M Slavik, E Kraut 9-l-91
Statisticians:PY Liu, D Daniels
Data Coordinator:J Straw
Objectives Stratification/Descriptive FactorsTo evaluate the response rate of disseminated mal- Patients are described by (1) performance status:ignant melanoma treated with merbarone. 0-1 vs 2; and (2) prior biologics: yes vs no.
To assess the qualitative and quantitative toxicities Accrual Goalsof merbarone administered in a Phase II study. Twenty eligible patients will be registered. If one
or more responses are observed, 20 additional pa-Patient Population tients will be accrued.Patients must have histologically proven, Stage IVmalignant melanoma. Measurable disease must be Summary Statementpresent. Twelve patients entered this study between Sep-
tember 1, 1991 and December 31, 1991. All arePrior chemotherapy is not allowed. Patients must eligible or have eligibility pending.have had at most one prior biologic regimen. Pa-tients may have had prior surgery and/or radio- Five patients have been evaluated for toxicity. No
therapy, fatal toxicities have occurred. Renal toxicities havebeen the most common toxicities, occurring in four
Patients must have a performance status of 0-2, as patients. One patient experienced Grade 4 creati-well as adequate renal, hepatic, and hematologic nine increase, proteinuria, and acute renal failurefunction. Patients must have no history of brain and was removed from treatment due to toxicity.metastases, history of myocardial infarction within Another patient was removed from treatment dueone year, nor evidence of congestive heart failure, to experiencing Grade 2 erythema.
Registration by Institution
(Registrations ending 31 DEC 9 I)
TOTAL I’OTA LINSTITUTION REG INSTITUTION REG
Michigan, U of 5 Roanoke Mem ltosp/Temple University IOregon Hlth Sci Univ 2 Thompson Ca Surv Clr/San Anlonio, U of TX IOklahoma, IJ of I Tulanc U IPresbyterian tlosp/New Mexico, U of I Totals (7 instiuaions) 12
Registration, Eligibility, and Evaluability
(Registrations ending 31 DEC 91; data as of 30 JAN 92)
Merbarone Merbarom,
NUMBER REGISTERED 12 TOXICITY ASSESSMENqINELIGIBLE 0 EvaluabIe 5ELIG./PEND. ELIG. 12 Too Early 7
Analyzable, Pend Elig. 4
I~.ESPONSE ASSESSMENTDeterminable 2Not Determinable 2To() Early 8
April 13-15, 1992 SOUTIIWEST ONCOLOGY GROUI’ MIFZLANOWIA 8913]11 O
(Registrations ending 31 DEC 9l; data as of 30 JAN 92)
Merbarone Merbarone(n = 12) (n = 12)
AGE PERFORMANCE STATUSMedian 64.0 PS 0-I II !)2%Minimum 30 PS 2 I 8%Maximum 73
PRIOR BIOLOGICSSEX Yes I 8%
Males 7 58°/,, No I [ 92%Females 5 42%
RACEWhite I 1 92%Black I 8°/;Other 0 0%
Number of Patients with a Given Type and Degree of Toxicity*
(Registrations ending 31 DEC 91; data as of 30 JAN 92)
Merbarone Merbarone(n = 5) (n ~ 5)
Grade Grade
U UN NTOXICITY K 0 1 2 3 4 5 TOXICITY K 0 I 2 3 4 5
AIk phos or 5’nucleotidase inc I 4 0 0 0 0 0 Proteinuria 0 3 0 I 0 [ 0Anorexia 0 4 I 0 0 0 0 Renal failure 0 4 0 0 0 I 0Creatimne increase 0 2 I I 0 I 0 Skin rash 0 4 0 I 0 0 0Iteadache 0 4 I 0 0 0 0 Vomiting I 4 0 0 0 0 0Hematuria 0 4 I 0 0 0 0Hypoglycemia 0 4 0 I 0 0 0 MAXIMUM GRADE ANY TOXICITYNausca I 3 0 I 0 0 0 Number 0 I 0 3 0 I 0
* Ineligibles and non-evaluables excluded. Discrepancies in totals are due to missing information.
10 MELANOMA 8913/n SOUTltWEST ONCOLOGY GROUP April 13-15, 1992
Phase II Trials of Cyclophosphamide/IL-2, DTIC/IL-2 andDTIC/Cisplatin/Tamoxifen in Stage IV Melanoma
Study Coordinators: Date Activated:L Flaherty, M Mitchell 2-15-90
Statisticians: Date Closed:PY Liu, D Danieis 9-1-91
Data Coordinator:J Straw
Schema
Arm 1:
Arm 2: . Progression orDTIC, IL-2 maximum duration m OFF treolment
Arm 3: /CDDP, DTIC,-Tamoxlfen
Obieetives skin and/or lymph nodes only vs any other sites.To evaluate the response rates in patients with dis- In addition, patients will be classified by 1) perFor-seminated malignant melanoma treated with one mance status: 0 vs 1, and 2) prior treatment forof three regimens: cyclophosphamide (CTX) and disseminated disease: yes vs no.IL-2; dacarhazine (DTIC) and IL-2; or DTIC, cis-platin (CDDP) and tamoxifen (TAM). Accrual Goals
For each arm, 15 eligible patients will be accruedTo assess the qualitative and quantitative toxicities in the first step. If one or more patients on an armassociated with each of the three regimens, respond, then 12 additional patients will be accrued
to that arm.Patient PopulationPatients must have histologically proven, Stage IV Summary Statementmalignant mehmoma which is measurable. Patients
This study was permanently closed September I,must not have symptomatic pleural effusions or as-1991. Arms I and 2 were closed October 15, 1990cites,due to a lack of available It-2. Because of the
Patients must have had no prior chemotherapy or positive results on SWOG 8804, the accrual goal FnrArm 3 was changed on December I, 1990 to 50IL-2 therapy for Stage IV disease. Patients may
have received prior surgery, radiation therapy, patients to estimate the response rule of the regimen
other prior immunotherapy for Stage IV disease, with greater precision.
and/or adjuvant therapy lor melanoma, not in- Data for Arms I and 2 will not be presented as parteluding IL-2, DTIC, or cisp[atin. At least 21 days of this report. A summary of these arms was lastmust have elapsed since the completion of treat- given in the Fall, 1991, Report of Studies.merit and patients mast have recovered from allside effects. Patients who have received prior ad- Arm 3: DTIC, CDDP, and Tamoxifenjuvant therapy that included IL-2, DTIC or cispla-tin are also eligible provided: 1) relapse did not Sixty-six patients were registered to Arm 3. Twelveoccur while the patient was on treatment and 2) at patients were ineligible: three because of inade-least six months have elapsed since the end of quate data submission, two because of missingtreatment, baseline tests, two because of inadequate pretreat-
ment creatinine clearance, and one each because ofPatients must have a performance status of 0-1 and an active infection requiring antibiotic therapy atadequate marrow, liver, cardiac, pulmonary and registration, ongoing cortisone therapy tit registra-kidney functions. Patients with known seizure dis- tion, baseline x-rays taken morc than 14 days priororders are not eligible, to registration, inadequate recovery fronl snrgery
at registration, and non-measurable disease. TenStratification/Descriptive Factors eligible patients had inadequate response assess-Patients will be stratified by sites of active disease: ments and are assumed to be non-responders: two
April 13-15, 1992 SOUTHWEST ONCOLOGY GROUP MI(LANOMA S921/11 I1
due to death before assessment and eight due to Grade 4 toxicities: creatinine increase, puhnonaryinadequate follow-up of disease sites. Six eligible edema, congestive heart failure, vomiting, granulo-patients were taken off of treatment due to toxicity; cytopenia, and lymphopenia. (In addition, one in-two due to renal toxicities and [’our due to nausea eligible patient died of renal insufficiency.) Elevenand vomiting with or without additional toxicities, other patients experienced Grade 4 toxicities. For-One eligible patient refused further treatment due ty-two patients (86%) experienced gastrointestinalto increased central nervous system symptoms, toxicities consisting mainly of nausea and vomiting.Three eligible patients were removed from treat- Thirty-eight patients (78%) experienced at least onement prematurely, hwestigators are encouraged to hematologic toxicity. Twenty-seven patients (55%)relier to Section 7.6 for the criteria for removal from experienced creatinine increase. The Grade 3 "Re-protocol treatment, hal-other" toxicity was elevated creatinine clear-
ante.Among the 49 eligible patients evaluated for toxic-ity, there was one fatal toxicity. The patient died Final results on this arm await response evaluationof remd failure after experiencing the following on patients with outstanding data.
Registration by InstitutionDTIC + CDDP + TAMOXIFEN
TOTAL TOTALINSTITUTION REG INSTITUTION REG
Oregon lllth Sci Univ 7 Thompson Ca Surv Ctr/San Antonio, U ofrXOhio Stale U 6 Allanta Reg CCOPKansas, U of 5 California tlCS CCOPOzarks Reg CCOP 4 Columbia River (?COPGrand Rapids CCOP 3 Columbus CCOPBAMC/WIIMC 2 Comanche County llosp/Oklahoma, IJ ofCentral IL (_COP 2 Dayton CCOPllenry Ford Hosp 2 Kentucky, U ofKaiser Foundaln }losp/Davis, U of CA 2 Oklahoma, U ofKansas City CCOP 2 Overlake Hospdal/Puget SoundMercy Itospital/Wayne State U 2 San Antonio, U of’ TXMichigan, U of 2 So Calif, U ofPuget Sound 2 St Luke’s Ilospdal/Arizona, U ofRiverskle Methodist/Ohio State U 2 Virginia Mason CCOPSpartanburg CCOP 2 Wayne State USt Vincent 1 lospital/Utah, U of 2 Wichita CCOPSW Florida Reg Med/Miami, U of 2 Totals (33 institutions) 66
Registration, Eligibility, and Evaluability
(Data as of 05 FEB 92)
DTIC + DTIC +CDDP + CDDP +Tamoxifen Tamoxifen
NUMBER REGISTERED 66 TOXICITY ASSESSMENTINELIGIBLE 12 Evaluable 49
Insufficient Documentation 5 Too Early 5ELIG./PEND. ELIG. 54
Analyzable, Pend. EIig. 6
RESPONSE ASSESSMENTDeterminable 32Not Determinable 10Too Early 12
12 MELANOMA 8921/1I SOUTHWEST ONCOLOGY GROUP April 13-15, 1992
AIopecia 0 48 0 I 0 0 0 Local 0 48 0 I 0 0 0Anemia I 30 3 9 5 I 0 Lymphopenia 0 23 6 7 10 3 0Anorexia 0 45 4 0 0 0 0 Malaise/fatigue/lethargy 4 38 2 4 I 0 0Anxiety/depression 0 48 0 0 I 0 0 Mya]gia/arthralgia 0 48 I 0 0 0 0Bilirubin increase 0 48 0 [ 0 0 0 Nausea 0 7 13 18 11 0 0Cardiac- EF/CHF 0 48 0 0 0 I 0 Neurosensory other 0 48 0 I 0 0 0Chills 0 48 I O 0 0 0 Pain I 48 0 0 0 0 0Constipation 0 48 0 I 0 0 0 Paresthesia 0 47 I I 0 0 0Creatinine increase 0 22 13 12 0 2 0 Proteinuria 0 48 I 0 0 0 0CNS ~ other 0 48 I 0 0 0 0 Pulmonary edema 0 48 0 0 0 I 0Diarrhea I 45 I 2 0 0 0 g. enal- other 0 48 0 0 I 0 0Dizziness/verligo I 47 I 0 0 0 0 Renal failure 0 48 0 0 0 0 IFever without infection 0 45 4 0 0 0 0 Small bowel obstruction 0 48 0 0 I 0 0Gastritis/ulcer 0 48 I 0 0 0 0 Taste 0 48 I 0 0 0 0Granulocytopenia 0 15 0 II 16 7 0 Thrombocytopenia 0 29 10 I 5 4 0Headache 0 48 I 0 0 0 Transaminase (SGOT, SGPT) inc 0 47 [ I 0 0 0Ilearing I 43 I 0 0 0 Urinary tract infection 0 47 I I 0 0 0llematuria 0 46 2 0 0 0 Vomiting 0 13 10 17 8 I 0l{ypokalemia 0 48 I 0 0 0 Weakness 0 47 2 0 0 0 0llyponatremia 0 48 0 I 0 0 Weight loss 0 46 2 I 0 0 (1llypotension 0 48 0 0 0 0hnpotence/]oss of libido 0 48 I 0 0 0 MAXIMUM GRADE ANY TOXICITYInfection 0 47 0 I 0 0 Number 0 2 2 8 25 II Il,cukopenia 0 20 10 7 [ 0
* Ineligibles and non-evaluabies excluded. Discrepancies in totals are due to missing information.
April 13-15, 1992 SOUTIIWEST ONCOLOGY GROUP MELANOMA 8921[11 13
SWaG 9035 Phase III
Randomized Trial of Adjuvant lmmunotherapy with an Allogeneic MelanomaVaccine for Patients with Intermediate Thickness, Node Negative Malignant
Melanoma (T3NOM0)
Study Coordinators:V Sondak, R Kempf, R Tuthill
Statisticians:PY Liu, D Daniels
Data Coordinator:J Straw
Schema
~~Vaccine Treatment x Two Years
Observation
Obiectivcs Patients must be registered within 56 days after lastTo compare the disease-free survival and overall surgery. Patients must not have had prior chemo-survival between patients with T3NOM0 malignant therapy, biologic therapy, or radiation therapy.melanoma who receive adjuvant immunotherapy Patients nmst have passed their 18th birthdays,with all allogeneic melanoma vaccine vs no adju- have a SWOG performance status 0-1, have ade-rant treatment, quate renal, hepatic, hematologic, and cardiac
functions. Patients requiring or expecting to re-To evaluate the toxicity of adjuvant immunether- quire treatment with corticosteroids are ineligible.apy with an allogeneic melanoma vaccine in pa- Stratification/Descriptive Factorstients with T3NOM0 malignant melanoma. Patients are stratified by (1) sex: male vs female;
(2) primary tumor thickness: T3a, 1.5-3.0 mm Patient Population T3b, 3.1-4.0 mm vs Clark’s level IV, Breslow’sPatients must have histologically diagnosed cuta- depth unknown; (3) prior lymph node dissection:neous malignant mehmmna of TNM classification no vs yes.T3NOM0 (1.5 - 4.0 mm or Clark’s level IV if
Accrual GoalsBreslow’s depth unknown, clinically and/or path- The accrual goal for this study is 420 patients. In-ologically negative lymph nodes). Patients must terim analyses will be performed when 60% andhave complete resection of all known sites of mela- 90% of the eligible patients are on study, and againnoma with no evidence of residual or metastatic at approximately one year after the completion ofmelanoma or lymph node involvement, accrual.
14 MELANOMA 9035/111 SOUTHWEST ONCOLOGY GROUP April 13-15, 1992
SWaG 9111 Phase llI Intergroup
Coordinating Group: ECOG (1690)
Post-Operative Adjuvant Interferon Alpha 2b (Intron A) in Resected High-RiskPrimary and Regionally Metastatic Melanoma
Iotergroup Participants: Date Activated:SWAG, ECOG, and CALGB. 5-15-91
Study Coordinators:L Flaherty, V Sondak, J Kirkwood (ECOG),J Richards (CALGB)
Statisticians:PY Lin, D Daniels
Data Coordinator:J Straw
Schema
One Year High-dose IFN Alpha 2
Arm B:Two Years Chronla Low-dose IFN Alpha 2
Arm C:Observation
Objectives ination of the cutaneous primary melanoma are notTo establish the efficacy of one year at maximally eligible.tolerable dosages (IV and SC) interferon alpha-2as an adjuvant to increase the disease-free survival Patients must have pathological confirmation ofand overall survival in patients at high risk for re- adequate surgical margins around the primary le-currence after definitive surgery for deep primary sion and a full lymphadeuectomy. A distal inter-lesions or after regional lymph node recurrence, phalangeal amputation is required lbr subungua[
melanoma. Patients who have received prior adju-To evaluate the efficacy and tolerance of long-term vant radiotherapy, chemotherapy, immunotherapyinterferon alpha-2 at 3 MU/d (SC TIW) as an ad- including preoperative infusion or perfusion ther-juvant to increase the disease-free survival and apy are ineligible. Patients with recurrent mela-overall survival of patients at high risk for recur- noma at regional lymph nodes who were previouslyfence after definitive surgery for deep primary le- entered on this study are ineligiblesions or after regional lymph node recurrence withmelanoma, in comparison to one year of treatment Patients must be 18-70 years old and have adequate
hematologic, renal, hepatic, and psychiatric func-of maximally tolerable dosages,tion. Patients must have no more than one lymph
Patient Population node group involved, and no history of cardiac
Patients must have either T4 NO M0-deep primary rhythm disturbance requiring treatment or of
melanoma (> 4.0 mm Breslow depth) with or with- congestive heart failure. Patients requiring ongoingtreatment with steroids, non-steroidal anti-infiam-out lymphadenectomy; or TI-4 NI M0-primary matory drugs, other prostaglandin synthetase inhi-
melanoma with regional lymph node metastasesbiters, H2 (cimetidine, rauitidine, famotidine, andfound at lymphadenectomy, but clinically unde-nazatidine), or other known imnmnodulators are
tectabIe (occult); or TI-4 N1-2 M0-primary mela- ineligible.noma with clinically apparent (overt) regionallymph node metastases confirmed by lymphade- Stratification/Descriptive Factorsnectomy; or TI-4 NI-2 M0-recurrence of mela- Patients will be stratified by (1) number of nodesnoma at the proximal regional lymph node(s) after positive at lymphadenectomy: 0 vs I vs 2-3 vsprior resection of the primary. Patients with clin- _> 4; and (2) stage of disease: T4 NO M0 (negativeical, radiological, laboratory, or pathological evi- regional lymph nodes, > 4.0 into Breslow depth) vsdence of incompletely resected melanoma, any TI-4 NI M0 (synchronous, occult positive regionaldistant metastatic disease, unknown primary site lymph nodes) vs TI-4 NI-2 M0 (synchronous, overtof mehmoma, primary melanoma originating apart positive regional lymph nodes) vs T 1-4 NI-2 M0from the skin, or a negative histopathologic exam- (recurrent positive regional lymph nodes).
April 13-15, 1992 SOUTIIWEST ONCOLOGY GROUP MELANOMA 9111/111 15
Accrual Goals Summary StatementFoul’ hundred Forty patients will be accrued to the Study 9111 was activated by Eastern Cooperative
study. Interim analyses will be performed when Ontology Group (ECOG) February, 1991 with theSouthwest Oncology Group joinglng as a partic-
25%, 50%, 75% of the expected relapses have been ipant May 15, 1991. By the end of 1991, 60 pa-observed, ttents were registered to this protocol. Of these, 21
were from the Southwest Oncology Grollp.
Registration by Institution
(Registrations ending 31 DEC 91)
TOTAL TOTAl.INSTITUTION REG INSTITUTION REG
Los Angeles, U of CA h’vine, U of CAOhio State U Kaiser Foundatn Hosp/Davis. U ol’ CAArkansas, U of Oregon llhh Sci UnivAtlanta Reg CCOP San Juan Reg Med Ctr/New Mexico, U ofCalifornia HCS CCOP South Alabama CCOPCohtmbia River CCOP Utah, U ofColumbus l lospital/Utah. U of Virginia Mason CCOPDayton CCOP Wayne State UGrand Rapids CCOP Totals (18 institutions) 21Greater Phoenix CCOP
I6 MELANOMA 9111/nl SOUTIIWEST ONCOI,OGY GROUP April 13-15, 1992
SWOG 9116 Phase II
Evaluation of Piroxantrone in Disseminated Malignant Melanoma
Study Coordinators:J Sosman, A Hantel
Statisticians:PY Liu, D Danieis
Data Coordinator:J Straw
Objectives Patients must have a SWOG performance status ofTo evaluate the response rate of disseminated real- 0-2, adequate hematologic, renal, cardiac and he-ignant melanoma treated with piroxantrone,
patic functions.To assess the qualitative and quantitative toxicitiesof piroxantrone administered in a Phase II study. Stratification/Descriptive FactorsPatient Population Patients will be stratified by RT status: RT to atPatients must have pathologically verified malig- least one hemipelvis and/or to >20% of the totalnant melanoma of TNM classification Mla or Mlb marrow containing bone mass: yes vs no. Patients(non-visceral or visceral sites). Patients with brain will be described by (1) performance status: 0-1 metastases are eligible if they have completed prior 2; (2) prior biologics: yes vs no; (3) brain metasta-radiotherapy, are clinically stable without progres-sive neurologic symptoms and have at least one ses: yes vs no.other site of distant metastasis. Patients must havehi-dimensionally measurable disease. Accrual Goals
Patients who have received prior chemotherapy or Twenty eligible patients will be registered. If one
more than one prior biologic regimen are ineligible, or more responses are observed, 20 additional pa-Prior radiation therapy and surgery are allowed, tients will be accrued.
April 13-15, 1992 SOUTItWEST ONCOLOGY GROUP MEI.ANOMA 9116/n 17
18 MELANOMA SOUTIIWEST ONCOLOGY GROUP April i3-15, 1992
