Thalidomide and Temozolomide or Camptothecin-11 (CPT-11) in Patients With Gliomas

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Objectives:

1.1 To determine the efficacy, as measured by 6 month progression-free survival, of therapy with thalidomide combined with CPT-11 in the treatment of patients with recurrent and/or progressive malignant gliomas.

1.2 To determine the rate of measureable clinical response in patients treated with Thalidomide and CPT-11.

1.3 To determine Thrombotic thrombocytopenic purpura (TTP), overall survival and unexpected toxicity of Thalidomide and CPT-11 used in recurrent malignant gliomas.

1.4 To determine changes in dynamic magnetic resonance imaging (MRI) as a surrogate marker for treatment effect.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Celgene Corporation
• Treatments: Irinotecan; Thalidomide

Criteria

Is there an age limit? No

Inclusion Criteria:

1. Patients with histologically proven supratentorial malignant primary gliomas (Glioblastoma multiforme (GBM), Gliosarcoma (GS) Anaplastic astrocytoma (AA), Anaplastic oligodendroglioma (AO), mixed anaplastic glioma (MAG)) will be eligible for this protocol.

2. Patients must have shown unequivocal evidence for tumor recurrence or progression by MRI scan after radiation therapy.

3. Patients in the GBM stratum may have had treatment for no more than 2 prior relapses; for the AA stratum, there is no limitation for the number of relapses provided all other eligibility criteria particularly the functional status are met.

4. All patients must sign an informed consent.

5. The baseline on-study MRI should be performed within 14 days prior to registration and on a stable or decreasing steroid dosage.

6. Patients having undergone recent resection of recurrent or progressive tumor will be eligible.

7. Patients must have a life expectancy > 8 weeks.

8. Patients must have a Karnofsky performance status of >= 70

9. 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, cis-retinoic acid, etc. (radiosensitizer does not count). Patients who receive either Temozolomide or CPT-11 for non-therapeutic purposes (such as presurgically for obtaining pharmacology data for the agent) will be eligible for study entry provided they have recovered from the toxic effects of the agent if any.

10. Patients must have adequate bone marrow function (Absolute neutrophil count (ANC)> 1,500/mm3 and platelet count of > 100,000/mm3), adequate liver function (alanine aminotransferase (ALT or SGPT) and alkaline phosphatase <2 times normal, bilirubin <1.5 mg/dl), and adequate renal function (blood urea nitrogen (BUN) and creatinine <1.5 times institutional normal) prior to starting therapy.

11. Patients must not be pregnant and must practice adequate contraception during the study and for 2 months after participation in study.

Exclusion Criteria:

1. Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible.

2. Patients must not have: a) active infection b) disease that will obscure toxicity or dangerously alter drug metabolism c) serious intercurrent medical illness. d) prior recurrence with CPT-11 (for the CPT-11 + Thalidomide arm) (prior treatment with thalidomide is permitted). e) grade 2 or higher peripheral neuropathy. Patients who have received Temozolomide or CPT-11 for non-therapeutic purposes (for eg., as part of a pharmacology study without therapeutic intent) will remain eligible for enrollment into the study.

3. No exclusion to this study will be based on race. Minorities will actively be recruited to participate. The malignant glioma patient population treated at MDACC over the past year is as follows: American Indian or Alaskan Native - 0 Asian or Pacific Islander - <2% Black, not of Hispanic Origin - 3% Hispanic - 6% White, not of Hispanic Origin - 88% Other or Unknown - 2% Total-100%