Status:
TERMINATED
Melphalan With BBBD in Treating Patients With Brain Malignancies
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving drugs directly...
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose of intra-arterial melphalan when given in combination with BBBD in patients with primary or metastatic central nervous system (CNS) malignancy. * De...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Signed written informed consent form in accordance with institutional guidelines
- Histologically confirmed primary or metastatic CNS malignancy (Patients with metastatic disease must have histological confirmation of the primary cancer AND confirmation by surgical specimen, cerebrospinal fluid cytology, elevated tumor markers, or clinical evidence of CNS involvement)
- Single or multiple cerebellar or cerebral cortex lesions allowed
- Life expectancy at least 60 days
- Radiographically evaluable disease by MRI or CT scan
- Age 18 years or older
- At least 28 days since prior radiotherapy (systemic, cranial, and/or spinal)
- At least 28 days since prior chemotherapy (42 days for nitrosoureas)
- Adequate cardiac and pulmonary function to tolerate general anesthesia
- Performance status of Eastern Cooperative Oncology Group (ECOG) 0-2
- Other tumor masses in the spinal cord allowed provided there is no radiographic or clinical evidence of spinal cord block
- Available for follow-up for at least one year following completion of treatment
- Fertile patients must use effective contraception for 2 months prior to, during, and for 3 months after study participation
- Pre-treatment lab tests within 14 days prior to initiation of treatment:
- White blood cell count (WBC) \> 2,500/mm\^3
- Absolute granulocyte count \> 1,200/mm\^3
- Platelet count \> 100,000/mm\^3
- Hematocrit \> 30% (transfusion allowed)
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- Serum glutamic oxaloacetic transaminase (SGOT) ≤ 3 times ULN
- Creatinine ≤ 2 times ULN
- Subjects with history of smoking or emphysema require diffusing capacity of lung for carbon monoxide (DLCO) ≥ 80% of predicted value for age
- Histological sections submitted for pathology review
- EXCLUSION CRITERIA:
- Radiographic evidence of excessive intra-cranial mass effect and/or spinal block
- Known hypersensitivity or intolerance to melphalan
- NCI CTC Grade 3 or greater baseline neurologic symptoms
- Immunologically compromised (Concurrent corticosteroids for tumor edema allowed)
- Unable to tolerate general anesthesia
- Pregnant, positive human chorionic gonadotropin (HCG) test, or lactating
- HIV positive
- Receiving concurrent radiotherapy or immunotherapy
- Serious illness that would preclude study participation
Exclusion
Key Trial Info
Start Date :
May 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00253721
Start Date
May 1 1998
End Date
December 1 2016
Last Update
April 21 2017
Active Locations (1)
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1
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098