Pyroxamide in Treating Patients With Advanced Cancer

Memorial Sloan Kettering Cancer Center

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

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

Interventions

pyroxamideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Data from ClinicalTrials.gov

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