CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as CC-8490, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of CC-8490 in treating patients who have recurrent or refractory high-grade gliomas.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed supratentorial malignant glioma, including any of the following:

• Glioblastoma multiforme

• Gliosarcoma

• Anaplastic astrocytoma

• Anaplastic oligodendroglioma

• Anaplastic mixed oligoastrocytoma

• Malignant glioma/astrocytoma not otherwise specified OR

• Clinical and radiographic diagnosis of progressive low-grade glioma

• Radiographically diagnosed infiltrating brain stem gliomas not amenable to biopsy allowed

• Recurrent or progressive disease as determined by 1 of the following:

• CT scan or MRI within the past 21 days

• Biopsy within the past 12 weeks

• Failed prior radiotherapy

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• More than 8 weeks

Hematopoietic

• Granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3 (transfusion independent)

• Hemoglobin at least 8 g/dL (transfusion allowed)

Hepatic

• Bilirubin no greater than 1.5 mg/dL

• AST and ALT no greater than 2 times upper limit of normal

• No significant active hepatic disease that would preclude study participation

Renal

• Creatinine no greater than 1.5 mg/dL OR

• Creatinine clearance at least 60 mL/min

• No significant active renal disease that would preclude study participation

Cardiovascular

• No significant active cardiac disease that would preclude study participation

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 2 months after study participation

• No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

• No significant active psychiatric disease that would preclude study participation

• No other condition or laboratory abnormality that would preclude study participation

• Able to swallow capsules whole

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 2 weeks since prior interferon

• No concurrent immunotherapy

Chemotherapy

• At least 2 weeks since prior vincristine

• At least 3 weeks since prior procarbazine

• At least 4 weeks since prior temozolomide or carboplatin

• At least 6 weeks since prior nitrosoureas

• No other concurrent anticancer chemotherapy

Endocrine therapy

• At least 2 weeks since prior tamoxifen

• Concurrent steroids allowed provided dose has been stable for at least 5 days prior to study enrollment

Radiotherapy

• See Disease Characteristics

• At least 2 weeks since prior radiotherapy

• No concurrent radiotherapy

Surgery

• At least 2 weeks since prior resection of a recurrent or progressive tumor

Other

• At least 2 weeks since other prior non-cytotoxic therapy

• At least 4 weeks since other prior cytotoxic therapies

• More than 28 days since prior experimental study drugs

• No other concurrent investigational agents