Pyroxamide in Treating Patients With Advanced Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma and Plasma Cell Neoplasm; Unspecified Adult Solid Tumor, Protocol Specific; Precancerous Condition; Chronic Myeloproliferative Disorders; Lymphoma; Leukemia; Myelodysplastic Syndromes; Small Intestine Cancer

Treatments: Drug: pyroxamide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00042900

99-090

NCI-2110

CDR0000069483 (Registry Identifier)

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of pyroxamide in treating patients who have advanced cancer.

Full description

OBJECTIVES:

• Determine the maximum tolerated dose of pyroxamide in patients with advanced malignancies.
• Define, qualitatively and quantitatively, the dose-limiting and non-dose-limiting toxic effects of this drug in these patients.
• Describe the pharmacologic behavior of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive pyroxamide IV continuously over 5-7 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of pyroxamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed monthly for resolution of adverse events.

PROJECTED ACCRUAL: A maximum of 32 patients will be accrued for this study.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed solid tumor or hematologic malignancy

  • Disease that has failed standard therapies (e.g., surgery, radiotherapy, endocrine therapy, or chemotherapy) or for which no curative or life- prolonging therapy is available

• Measurable or clinically evaluable disease

  • Elevated tumor marker is acceptable for evaluable disease

• No known carcinomatous meningitis, primary brain tumors, or metastatic brain disease

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 125,000/mm^3
• Hemoglobin at least 9.0 g/dL

Hepatic

• Bilirubin normal
• AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
• PT no greater than 1.5 times ULN

Renal

• Creatinine normal

Other

• HIV-positive status allowed
• Prior malignancy allowed
• No severe physical or emotional illness that would preclude study participation
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent bone marrow growth factors

Chemotherapy

• See Disease Characteristics
• At least 4 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• See Disease Characteristics
• At least 4 weeks since prior wide-field radiotherapy and recovered
• At least 2 weeks since prior limited-field radiotherapy and recovered
• Recovered from prior radiotherapy

Surgery

• See Disease Characteristics

Other

• No other concurrent antitumor treatment