VNP40101M and Temozolomide in Treating Patients With Progressive or Relapsed Malignant Glioma

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

Summary

RATIONALE: Drugs used in chemotherapy, such as temozolomide and VNP40101M, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Temozolomide may also stop the growth of tumor cells by blocking blood flow to the tumor.

PURPOSE: This phase I/II trial is studying the side effects and best dose of VNP40101M when given together with temozolomide and to see how well it works in treating patients with progressive or relapsed malignant glioma.

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

Details

• Lead Sponsor: Northwestern University
• Collaborator: Vion Pharmaceuticals
• Treatments: Dacarbazine; Temozolomide

Criteria

DISEASE CHARACTERISTICS:

Inclusion criteria:

• Histologically proven malignant glioma including any of the following:

• Glioblastoma multiforme

• Gliosarcoma

• Anaplastic astrocytoma

• Anaplastic oligodendroglioma

• Anaplastic mixed oligoastrocytoma

• Malignant astrocytoma not otherwise specified

• Unequivocal evidence of tumor recurrence or progression by MRI or CT scan with contrast

• No more than one relapse

• Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:

• More than 2 weeks from surgery and have recovered from the effects of surgery

• Evaluable or measurable disease following resection of recurrent tumor is not mandated for eligibility into the study if a treatment failure can be evaluated

• Enhanced CT scan/ MRI should be done no later than 96 hours in the immediate post-operative period or 4-6 weeks post-operatively

• If the 96-hour scan is more than 2 weeks from registration, the scan needs to be repeated

• A baseline scan should be performed within 14 days prior to registration and on a steroid dosage that has been stable for 5 or more days otherwise a new baseline MRI/CT is required

• The same type of scan (i.e., MRI or CT scan) must be used throughout the period of protocol treatment for tumor measurement

• Must have failed prior external-beam radiotherapy

• Must have failed one prior systemic treatment with chemotherapy or biologic agents

PATIENT CHARACTERISTICS:

Inclusion criteria:

• Karnofsky performance status 60-100%

• Life expectancy > 12 weeks

• WBC > 3,000/mm³

• ANC > 1,500/mm³

• Platelet count > 100,000/mm³

• Hemoglobin > 10 mg/dL

• AST and ALT < 4 times upper limit of normal (ULN)

• Bilirubin < 2 times ULN

• Creatinine < 1.5 times ULN

• Fertile patients must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device)

• Negative pregnancy test

• Not pregnant or nursing

Exclusion criteria:

• Active uncontrolled bleeding

• Active infection of any kind

• Unwilling or unable to follow protocol requirements or to give informed consent

• Active heart disease including any of the following:

• Myocardial infarction within the past 3 months

• Uncontrolled arrhythmias

• Uncontrolled coronary artery disease

• Uncontrolled congestive heart failure

• Known HIV-positive patients (HIV testing is not required)

• History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission and off all therapy for that disease for a minimum of 3 years

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

• See Disease Characteristics

• Recovered from prior therapy

• At least 2 weeks since prior vincristine

• More than 4 weeks since prior cytotoxic therapy (6 weeks for nitrosoureas)

• More than 4 weeks since prior radiotherapy

• More than 4 weeks since prior experimental biologic agents (e.g., EGFR inhibitors, etc)

• More than 3 weeks since prior procarbazine administration

• More than 2 weeks since prior non-cytotoxic agents (e.g., interferon, tamoxifen, thalidomide, or isotretinoin)

• Radiosensitizer does not count

• At least 2 weeks since prior and no concurrent enzyme inducing anticonvulsants

• If patient is on an enzyme inducing anticonvulsant, they may be converted to a non-enzyme inducing anticonvulsant

Exclusion criteria:

• Any other concurrent standard or investigational treatment for cancer, or any other investigational agent for any indication

• Concurrent disulfiram