Post on 23-Jan-2015
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Status Update 2009
Michael J. Fisch, MD, MPH, FACPMedical Director
The Future is NOW
ID00-156 (NCI 3410)A Prospective Randomized Phase III Trial Comparing Consolidation Therapy with or without Strontium-89 Following Induction Chemotherapy in Androgen-Independent Prostate Cancer
Principal Investigator: Shi-Ming Tu, MD, M. D. Anderson Cancer Center
Patient Population: A total of about 480 patients with androgen-independent prostate cancer will be accrued for the study. 218 enrolled so far.
Treatment: Active
Option 1Ketoconazole/doxorubicinAlternating withEstramustine/vinblastine
Option 2Prednisone/docetaxel
RANDOMIZE
Sr-89 plus doxorubicin x 6 weeks
Doxorubicin x 6 weeks
Clinical Response
16 weeks
2004-0662 (NCI 6636)A Randomized, Factorial-Design, Phase II Trial of Temozolomide Alone and in Combination with Possible Permutations of Thalidomide, Isotrentinoin and/or Celecoxib as Post-Radiation Adjuvant Therapy of Glioblastoma Multiforme
Principal Investigator: Mark R. Gilbert, MD, M. D. Anderson Cancer Center
Patient Population:
Maximum number of patients is 176. Patients must have a diagnosis of supratentorial glioblastoma multiforme.
109 patients enrolled so far
Treatment: Active
Temozolomide Other Agent(s)
CR,PRorSD
PD
IneligibleCR=complete response, PR=partial response,
SD=stable disease, PD=progressive disease
TMZ-temozolomide; Thal-thalidomide;
CRA-cis-retinoic acid (isotretinoin); Cel-celocoxib
Reg
. &
Ran
do
m.
RT
Max. =5 wks
Sur
gery
or
Bio
psy
1 TMZ None
2 TMZ + Thal
3 TMZ + CRA
4 TMZ + Cel
5 TMZ + Thal/CRA
6 TMZ + Thal/Cel
7 TMZ + CRA/Cel
8 TMZ + Thal/CRA/Cel
2004-0305 (NCI 6485)A Phase II Study of Rituximab-CHOP with Pegylated Liposomal Doxorubicin in Patients Older than 60 Years of Age with Untreated Aggressive B-Cell Non-Hodgkin’s Lymphoma
Principal Investigator: Maria A. Rodriguez, MD, M. D. Anderson Cancer Center
Methodology:• Rituximab 375 mg/m2 IVPB on day 1, administered 1st • Cyclophosphamide 750 mg/m2 IVPB on day 1• Pegylated liposomal doxorubicin 40 mg/m2 (maximum dose 90 mg) IV infusion over
1 hr on day 1• Vincristine 2.0 mg IV, day 1• Prednisone 40 mg/m2 P.O. days 1-5• Either GCSF 5 mcg/kg, SC daily, start on day 5, until
neutrophil recovery (absolute neutrophils >3000/ul)• or Pegylated GCSF (Neulasta) 6 mg SC x1 (24 hours after chemotherapy)
Courses will be repeated every 21 days, provided the absolute neutrophil count is >1000/ul, the platelet count is >100,000/ul and Troponin I levels are not elevated (> 1.4).
Patient Population: A maximum of 80 patients will be accrued. Patients will be older than 60 years of age with untreated aggressive B-cell Non-Hodgkin’s Lymphoma. 70 patients enrolled so far.
Treatment: Active
2006-0260 (NCI 7548)Single-arm, Open-label, Phase II Trial of Rituximab plus Sargramostim for the Treatment of Newly Diagnosed Follicular B-cell Lymphoma in Adults
Principal Investigator: Peter McLaughlin, MD, M. D. Anderson Cancer Center
Patient Population: Patients to be enrolled (n=52) in this study will have histologically confirmed, newly diagnosed follicular B cell lymphoma. 48 enrolled so far!
Treatment: Active
Study Schema
Week of Study
Day Rituximab1
(mg/m2)GM‑CSF2
(μg)*Exams
and LabsLesion
AssessmentRe‑staging
1‑4 1 375 250 X
3 250
5 250
5‑8 1 250 X X
3 250
5 250
1.Rituximab should be administered on day 1, 8, 15, & 22. 2.GM-CSF should be administered on day 1, 3, & 5 weekly for 8 weeks (24 doses)
Cancer Control Trials Dominate
73/83 enrollments in February 2009 were cancer control
The New Model: The M. D. Anderson Cancer Control CCOP Research Base
• Palliative Care
• Cytokines & Supportive Oncology
• Symptom Science
• Behavioral Medicine
• Integrative Medicine
• Survivorship
2004-0024 (NCI CCC01-06)Chemotherapy and Mindfulness Relaxation: A Randomized Trial at M. D. Anderson Cancer Center and M. D. Anderson Community Clinical Oncology Program
Principal Investigators: Jon Hunter MD, FRCP©; Mount Sinai Hospital, Toronto, CanadaLorenzo Cohen, PhD, M. D. Anderson Cancer Center
Community Co-Investigator: Judith Huber, RN, Marshfield CCOP
Patients with newly-diagnosed cancer, who are about to undergo chemotherapy, and give informed consent, will be randomly assigned to one of three groups:
• The Mindfulness Relaxation group [MR];
• A Relaxing Music group [RM] where participants will listen to music for the same amount of time as the MR participants receive their intervention;
• A Standard Care control group where participants will receive standard medical education on chemotherapy [SC].
Patient Population: Target accrual 375 subjects, current accrual 136
Cancer Control: Active
2004-0728 (NCI CCC 03-27)Prevention of Cisplatin- or Oxaliplatin-induced Peripheral Neuropathy with Alpha-lipoic Acid: A Placebo-controlled Phase III Trial
Principal Investigator: Ying Guo, MD, M. D. Anderson Cancer Center
Patient Population:
This study will enroll both male and female patients, who plan to receive chemotherapy that contains platinum in their regimen. Patients will receive treatment in an outpatient setting. The study is a randomized, double-blind, phase III trial, with 85 evaluable patients assigned to each of the two treatment groups. A total of 244 patients will be accrued, and 191 enrolled so far.
Cancer Control: Active
2005-0839 (NCI 7341)A Phase II Study of Gemcitabine, Paclitaxel, and Doxorubicin, with Same-day Pegfilgrastim for the Treatment of Patients with Metastatic Transitional Cell Carcinoma and Renal Insufficiency
Principal Investigator: Lance C. Pagliaro, MD, M. D. Anderson Cancer Center
Methodology:In this single-arm phase II protocol, patients with creatinine clearance < 60 ml/min will receive doxorubicin plus paclitaxel and gemcitabine. Treatment will be administered on an outpatient basis. All patients will receive: doxorubicin 40 mg/m2 IV over 20 min; paclitaxel 135 mg/m2 IV over 60 min; gemcitabine 900 mg/m2 IV over 90 min; repeat every 14 days. All patients will receive pegfilgrastim 6 mg SC on day 1 or day 2 of each course.
Patient Population: Patients to be enrolled in this study (n = 72) must have histologically or cytologically confirmed metastatic or unresectable transitional cell (TCC) carcinoma of bladder, urethra or upper urinary tract. Mixed TCC and variant histologies (small cell, squamous, adenocarcinoma, sarcoma) are permitted if present in < 50% of the biopsy specimen.
Treatment: Active
2006-0198 (NCI MDA 2006-0198)CAM Use and CancerPrincipal Investigator: Patricia Ann Parker, PhD, M. D. Anderson Cancer Center
Patient Population: The study population will be composed of oncology nurses/providers who have consented to participate in this study at each individual participating CCOP site that has agreed to take part in this study. 185 enrolled of 680 target accrual.
Cancer Control: Active
Baseline Patient Assessment
Random Assignment to Intervention or Waitlist Control
Baseline Provider Assessment
CD/Video and Resource List
Baseline Provider Assessment
Enrollment of Nurses/Providers at Participating CCOPs
CD/Video and Resource List
1 Week
Provider and Patient Follow-Up Assessment Provider and Patient Follow-Up Assessment2 Weeks
Provider and Patient Follow-up Assessment Provider and Patient Follow-up Assessment2 Months
2006-0841 (NCI MDA 2006-0841) Randomized, Double-Blind, Placebo-Controlled Trial of Palonosetron/ Dexamethasone with or without Dronabinol for the Prevention of Chemotherapy-induced Nausea and Vomiting after Moderately Emetogenic ChemotherapyPrincipal Investigator: Steven Grunberg, MD, University of Vermont Hematology/Oncology Unit,
Burlington, Vermont Co-PI: Michael J. Fisch, MD, M. D. Anderson CCOP Research Base Community Co-Investigator: Jeffery Giguere, MD, Greenville CCOP, Greenville, South Carolina
Methodology:All patients receive palonosetron 0.25 mg IV and dexamethasone 10 mg IV 30 minutes prior to administration of chemotherapy. Patients are randomized to take dronabinol 5 mg or matched placebo: 1 tablet by mouth 3 times a day for 5 days beginning 30 minutes before chemotherapy. Blood tests and informed consent prior to start of therapy. Patients will answer the modified MANE instrument questions day 1 through 5 after the administration of chemotherapy as well as keep a daily diarrhea diary.
There will be a follow-up physical examination and assessment between day14 through 28. The primary endpoint will be Total Protection: No Vomiting, No Rescue Therapy and no nausea during the overall (0-120 hour) period. The secondary endpoints will be No Vomiting, No Significant Nausea, No Nausea, Complete Protection and Complete Response evaluated for the Acute (0-24 hour), Delayed (24-120 hour), and Overall (0-120 hour) periods.
Patient Population: The study population will be composed of 100 patients in each treatment group (200 patients total). Patients will be 18 years old or older, have a histologically or cytologically documented solid tumor and be receiving chemotherapy for the first time. JUST OPENED!
Cancer Control: Active
2007-0791 (NCI MDA 05-08-04)A Randomized Comparison of Oral Methadone as a “First-Switch” Opioid versus Opioid Switching Between Sustained-Release Morphine and Oxycodone for Oncology-Hematology Outpatients with Pain Management Problems: The “Simply Rotate” Study
Principal Investigator: Michael J. Fisch, MD, M. D. Anderson CCOP Research Base
Patient Population: The study population will be composed of 300 patients recruited from the outpatient oncology setting. JUST ACTIVATED!
Cancer Control: Active
Oncology outpatient with chronic pain requiring long-acting, strong opioid analgesic such as morphine, hydromorphone, oxycontin, or transdermal fentanyl AND: Persistent pain ≥ 5/10 in severity at its worst OR one or more persistent and bothersome opioid side effects such as constipation, nausea, sedation/mental clouding or myoclonus.
Consent & Registration
Calculate the morphine oral equivalent daily dose (MEDD) of the currently used strong opioid(s)
RANDOMIZATION
Switch to oral methadone-based opioid regiment
Switch to another strong opioid (not methadone)
Telephone assessments (or face-to-face assessments) for pain relief and toxicity on Days 8, 15, and 22
Study completion visit on Day 28 (+/- 3 days) to assess the primary endpoint
2008-0005 (NCI MDA 2008-0005)Phase II, Randomized, Double Blind Comparison of CASAD vs. Placebo for the Treatment and Prevention of Diarrhea in Patients with Metastatic Colorectal Cancer
Principal Investigator: Katrina Glover, MD, M. D. Anderson Cancer Center
Methodology:
CASAD / placebo will be provided by Salient Pharmaceuticals incapsules that are taken as 2 capsules four times daily. EachCASAD capsule contains 500 mg HCAS. Placebo will be provided in a similar color and shape as CASAD. A 2-hour window will be required between administration of CASAD/placebo and all other medications. CASAD / placebo should be started at least one hour prior to receiving chemotherapy.
Patient Population: A maximum of 100 patients will be randomized equally between two arms, 50 per arm. JUST ACTIVATED!
Cancer Control: Active
R
6 WeeksCASAD -------------------------- Off Study/Optional Additional 6 Weeks
Placebo -------------------------- Off Study/Optional Additional 6 Weeks
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The Product
• Calcium Alumino-Silicate (CAS) based pharmaceutical– Administered in capsules, tablets and oral
suspension dose form
• Raw material is a naturally occurring mineral– No dioxins, heavy metals at limits of detection
• GRAS substance, FDA approved food and feed additive
• Proven to absorb a range of toxins and inflammatory proteins
Calcium Alumino-Silicate
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Mechanism – Selective Ionic Trapping
• Irinotecan - No chemical reaction (Carpenter, Newman, 2007)
• Trapped chemical bound to CAS in vitro > 99%
Coming Attractions
• PREDICT study: using biomarkers to detect and identify cardiotoxicity in patients receiving anthracyclines– Concept approved, protocol being submitted– Cardiology & Oncology Partnership
Coming Attractions
• Trimethoprim-EDTA to prevent CVC-catheter occlusions (Raad)
– We have previously presented information concerning the protocol “Prospective, Randomized Trial Comparing Heparin and Minocycline-EDTA Flush for the Prevention of Catheter-Related Infections and Occlusions.” The protocol was NCI-approved. Now we will be modifying this protocol to compare trimethroprin-EDTA in 25% ethanol with saline. We will resubmit to the NCI. Great Lakes Pharmaceuticals (GLP), the sponsor, is preparing to manufacture the supply kits that will be used during the conduct of this trial
• Questions for you– Which catheters do you use?– Heparin vs. saline for flush? Lock?– Simultaneous (peripheral and CVC) drawn blood cultures—is it feasible for you?
Coming Attractions
• Oncologist-Assisted Home Exercise Program for Advanced Colon Cancer Patients (Basen-Engquist)– Enrollment plan is for the CCOPs– R21-funded just this week!!