EMD 121974 in Treating Patients With Progressive or Recurrent Glioma

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: EMD 121974 may stop the growth of cancer by stopping blood flow to the tumor.

PURPOSE: Phase I/II trial to study the effectiveness of EMD 121974 in treating patients who have progressive or recurrent malignant glioma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New Approaches to Brain Tumor Therapy Consortium
• Collaborator: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed malignant glioma that is progressive or recurrent after radiotherapy and/or chemotherapy

• Eligible subtypes:

• Anaplastic astrocytoma

• Anaplastic oligodendroglioma

• Glioblastoma multiforme

• Prior low-grade glioma that has progressed to a high-grade glioma (by biopsy) after radiotherapy and/or chemotherapy allowed

• Measurable disease by volumetric and magnetic resonance perfusion scan

• Prior biopsy or resection of recurrent brain tumor allowed

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin normal

• Transaminases no greater than 2.5 times upper limit of normal

Renal:

• Creatinine no greater than 1.5 mg/dL OR

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No advanced coronary artery disease

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No serious concurrent infection or medical illness that would preclude study

• No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer

• No history of wound healing disorders

• No peptic ulcer disease within the past year

• Mini mental score of at least 15

• Willing and able to undergo MRI

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent filgrastim (G-CSF)

Chemotherapy:

• See Disease Characteristics

• At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

• No more than 2 prior chemotherapy regimens

Endocrine therapy:

• Prior corticosteroids allowed if on stable dose for at least 5 days prior to study

• Concurrent corticosteroids (e.g., dexamethasone) allowed as clinically needed

Radiotherapy:

• See Disease Characteristics

• At least 3 months since prior radiotherapy and recovered

Surgery:

• See Disease Characteristics

• At least 1 week since prior surgery and recovered

• No concurrent elective surgery or dental extractions

Other:

• No other concurrent investigational agents