Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioma

Glioblastoma

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Irinotecan

Thalidomide

Temozolomide

Camptothecin

Topoisomerase I Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Angiogenesis Inhibitors

Growth Inhibitors

Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m\^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.

125 mg/m\^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest

CPT-11

Dynamic MRI scan with dye injection through vein, every 6 weeks

MRI Scan

QST, every 12 weeks, to check for any nerve problems that may be present before starting treatment; by touching a small machine tests are done on feeling of touch, vibration, and temperature.

Quantitative Sensory Tests (QST)

Vinay K. Puduvalli, MD

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.

Thalidomide is a drug that interferes with the growth of blood vessels. Thalidomide may help to decrease the blood supply in the tumor and make it unable to grow. CPT-11 is a drug that was designed to stop cancer cells from dividing.

All participants will take thalidomide capsules by mouth every evening at bedtime. You will begin with 1 capsule every night for the first week then increase to 2 capsules every night for a week and then 3 capsules a night for the third week. After that, you will increase the dose to 4 capsules each night for the rest of the study. The dosages may be adjusted if you experience any severe side effects.

In addition to thalidomide, you will receive treatment with CPT-11 through a continuous injection into a vein over 90 minutes once a week for 4 weeks followed by 2 weeks of rest from the drug. This 6 week period is called a course of therapy. The courses of therapy will be repeated as long as the disease is responding to treatment for up to 2 years.

THIS IS AN INVESTIGATIONAL STUDY. Both drugs are commercially available. Thalidomide and CPT-11 are FDA approved for the treatment of some cancers. The combination of these drugs is investigational.

Up to 78 participants will take part in this study. All will be enrolled at M. D. Anderson.

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

A Phase II Trial of Combination Therapy With Thalidomide and CPT-11 in Patients With Recurrent Anaplastic Gliomas or Glioblastoma Multiforme

Progression-free Survival (PFS) measured as number of participants that are alive and progression-free at 6 months.

Celgene Corporation

M.D. Anderson Cancer Center

The endpoints combined results of all strata

Patients With Recurrent Malignant Gliomas

Glioblastoma Multiforme: Thalidomide + CPT-11

Anaplastic Gliomas: Thalidomide + CPT-11

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Vinay Puduvalli, MD / Associate Professor

The endpoints combined results of all strata (Arm 1 of Glioblastoma Multiforme: Thalidomide + CPT-11 and Arm 2 of Anaplastic Gliomas: Thalidomide + CPT-11).

Participants With Recurrent Malignant Gliomas

7 participants enrolled were not evaluated as they were evaluable for toxicity only (not having completed the first cycle/clinical decline/etc.).

Number of Participants Progression Free at 6 Months With Malignant Gliomas

Overall Study

Spots Global Cancer Trial Database for quantitative sensory tests (qst)