Overview

Phenylbutyrate Plus Azacitidine in Treating Patients With Acute Myeloid Leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Multiple Myeloma, Non-small Cell Lung Cancer, or Prostate Cancer

Status:
Completed
Trial end date:
2003-08-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of phenylbutyrate plus azacitidine in treating patients who have acute myeloid leukemia, myelodysplasia, non-Hodgkin's lymphoma, multiple myeloma, non-small cell lung cancer, or prostate cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
4-phenylbutyric acid
Azacitidine
Criteria
DISEASE CHARACTERISTICS:

- Diagnosis of one of the following neoplastic diseases:

- Acute myeloid leukemia

- Myelodysplasia

- Low or intermediate grade non-Hodgkin's lymphoma

- Multiple myeloma

- Non-small cell lung cancer

- Prostate cancer

- Failed prior conventional therapy and no other known curative therapy exists

- Patients with non-Hodgkin's lymphoma, non-small cell lung cancer, and prostate cancer
must have tumor cells in bone marrow or malignant effusions that are accessible for
bone marrow aspiration or paracentesis/thoracentesis NOTE: A new classification scheme
for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of
"indolent" or "aggressive" lymphoma will replace the former terminology of "low",
"intermediate", or "high" grade lymphoma. However, this protocol uses the former
terminology.

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified

Hematopoietic:

- Patients without leukemia or myeloma:

- WBC at least 2,500/mm^3

- Platelet count at least 75,000/mm^3

Hepatic:

- Bilirubin no greater than 2.5 mg/dL

Renal:

- Creatinine no greater than 2.5 mg/dL

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 4 weeks after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Patients without leukemia:

- At least 3 weeks since prior cytotoxic chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- Patients without leukemia:

- At least 3 weeks since prior radiotherapy

Surgery:

- Not specified