Non Hodgkin Lymphoma Clinical Trial
Pyroxamide in Treating Patients With Advanced Cancer
Summary
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.
Eligibility 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
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There is 1 Location for this study
New York New York, 10021, United States
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