A Phase I/II Study of TPI 287 - Temozolomide Combination in Melanoma
This study is currently recruiting participants.
Verified June 2012 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Archer Biosciences, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01067066
First received: February 9, 2010
Last updated: June 8, 2012
Last verified: June 2012
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The goal of the Phase I portion of this study is to find the highest tolerable dose of TPI 287 that can be given in combination with Temodar (temozolomide) to patients with metastatic melanoma.
The goal of the Phase II portion of this study is to learn if TPI 287, given in combination with temozolomide, can control metastatic melanoma. The safety of this combination will also be studied.
Condition | Intervention | Phase |
---|---|---|
Melanoma |
Drug: TPI 287 Drug: Temodar (Temozolomide) |
Phase 1 Phase 2 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | A Phase I/II Open-Label Study TPI 287 in Combination With Temozolomide in Patients With Metastatic Melanoma |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) [ Time Frame: 28 day study cycle ] [ Designated as safety issue: Yes ]
Estimated Enrollment: | 106 |
Study Start Date: | February 2010 |
Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: TPI 287 + Temodar
Starting dose of TPI 287 90 mg/m^2 IV on Days 1, 8, 15 + Temozolomide (Temodar) PO at 85 mg/m^2 on Days 1-5.
|
Drug: TPI 287
Starting dose cycle 1, 90 mg/m2 by vein (IV) on Days 1, 8, 15 (+/- 1 day)
Drug: Temodar (Temozolomide)
Starting dose cycle 1, 85 mg/m^2 by mouth (PO) daily, Day 1 to 5.
Other Name: Temozolomide
|
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Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with histologically proven melanoma with metastasis that is unresectable Stage III or Stage IV. This will include bulky stage III and M1-3. Patients with melanoma with documented metastases to the brain are eligible.
- Patients must have shown unequivocal evidence for tumor recurrence or progression and should have at least one indicator lesion, that can be measured in one dimension as >/=20mm with conventional techniques (CT, MRI, X-ray) or >/=10mm with spiral CT scan.
- Patients may have had up to two prior cytotoxic chemotherapy regimens for their disease (immunological or targeted therapy e.g. vaccine, IL-2, B-RAF inhibitors, will not be considered prior cytotoxic chemotherapy). Patient should not have been treated with Docetaxel, Paclitaxel or other taxanes.
- All patients must sign an informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of this hospital.
- Patients must have a Eastern Cooperative Oncology Group status of </=2.
- Patients must have recovered from the toxic effects of prior therapy: 4 weeks from prior cytotoxic therapy and/or at least two weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc. (radiosensitizer does not count). Any questions related to the definition of non-cytotoxic agents should be directed to the Study Chair.
- Patients must have adequate bone marrow function (ANC >/= 1,500/mm3 and platelet count of >/= 100,000/mm3), adequate liver function (SGPT and SGOT </= 2.5 times normal, bilirubin </= 2 mg/dl), and adequate renal function (BUN and creatinine </=1.5 times institutional normal) prior to starting therapy.
- TPI 287 may interfere with coumadin dosing and patients who are taking this combination will require monitoring of their PT, PTT and INR.
- Females of childbearing potential (non-childbearing is defined as greater than one year post-menopausal or surgically sterilized) must use acceptable contraceptive methods (abstinence, intrauterine device, oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 7 days prior to beginning treatment on this trial. Sexually active men must also use acceptable contraceptive methods for the duration of time on study.
- Patient should be 15 years of age or older
Exclusion Criteria:
- Patients with brain metastases must not be taking primidone, carbamazepine, phenobarbital or phenytoin anticonvulsants (Enzyme-Inducing Anti-Epileptic Drugs). Patients changing from these anticonvulsants to others that are allowed must be off the drugs listed above for at least 1 week.
- Patients with any neuropathy.
- Patients with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, history of myocardial infarction within the previous six months, or serious uncontrolled cardiac arrhythmia.
- Because of the concerns of potentially harmful interactions of TPI 287and other medications taken by patients who are HIV positive or have AIDS related diseases, patients who are HIV positive are not be eligible for entry into this study. Only patients with suspected HIV will be tested and if positive, will be ineligible.
- Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) are ineligible for Phase II part of the study unless in complete remission and off of all therapy for that disease for a minimum of 3 years. However, during Phase I part of the study, a patient with second malignancy is eligible if that malignancy has not recurred after appropriate therapy.
- Patients with: a) active infection, b) disease that will obscure toxicity or dangerously alter drug metabolism, c) serious intercurrent medical illness, d) prior documented recurrence with temozolomide
- Females who are pregnant or breastfeeding.
- Patients younger than 15 years of age
- Patients with prior therapy with paclitaxel or other taxanes.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01067066
Contacts
Contact: Agop Y. Bedikian, MD, BS | 713-792-2921 |
Locations
United States, Texas | |
UT MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Agop Y. Bedikian, MD, BS |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Archer Biosciences, Inc.
Investigators
Study Chair: | Agop Y. Bedikian, MD, BS | UT MD Anderson Cancer Center |
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Additional Information:
No publications provided
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT01067066 History of Changes |
Other Study ID Numbers: | 2009-0357 |
Study First Received: | February 9, 2010 |
Last Updated: | June 8, 2012 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
TPI 287 microtubule inhibitor Temozolomide Temodar |
cytotoxic agent unresectable Stage III Stage IV Metastatic Melanoma |
Additional relevant MeSH terms:
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on October 17, 2012