Pyroxamide in Treating Patients With Advanced Cancer

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Precancerous Condition; Small Intestine Cancer; Unspecified Adult Solid Tumor, Protocol Specific	Drug: pyroxamide	Phase 1

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Primary Purpose:	Treatment
Official Title:	A Phase I Clinical And Pharmacological Study Of Pyroxamide (NSC 696085) In Patients With Advanced Malignancies
Study Start Date :	April 2002
Actual Primary Completion Date :	September 2002
Actual Study Completion Date :	September 2002

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:	Leonard B. Saltz, MD	Memorial Sloan Kettering Cancer Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00042900 History of Changes
Other Study ID Numbers:	99-090; CDR0000069483 ( Registry Identifier: PDQ (Physician Data Query) ); NCI-2110
First Posted:	July 8, 2003
Last Update Posted:	June 5, 2013
Last Verified:	June 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:

AIDS-related peripheral/systemic lymphoma; AIDS-related primary CNS lymphoma; T-cell large granular lymphocyte leukemia; Waldenström macroglobulinemia; accelerated phase chronic myelogenous leukemia; acute undifferentiated leukemia; adult acute lymphoblastic leukemia in remission; adult acute myeloid leukemia in remission; primary myelofibrosis; anaplastic large cell lymphoma; angioimmunoblastic T-cell lymphoma; blastic phase chronic myelogenous leukemia; chronic myelomonocytic leukemia; chronic phase chronic myelogenous leukemia; de novo myelodysplastic syndromes

essential thrombocythemia; extramedullary plasmacytoma; intraocular lymphoma; isolated plasmacytoma of bone; meningeal chronic myelogenous leukemia; monoclonal gammopathy of undetermined significance; polycythemia vera; previously treated myelodysplastic syndromes; primary central nervous system non-Hodgkin lymphoma; primary systemic amyloidosis; progressive hairy cell leukemia, initial treatment; prolymphocytic leukemia; recurrent adult Hodgkin lymphoma; recurrent adult T-cell leukemia/lymphoma; recurrent adult acute lymphoblastic leukemia

Additional relevant MeSH terms:

Lymphoma; Syndrome; Leukemia; Multiple Myeloma; Neoplasms, Plasma Cell; Myelodysplastic Syndromes; Preleukemia; Plasmacytoma; Myeloproliferative Disorders; Precancerous Conditions; Intestinal Neoplasms; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases	Immunoproliferative Disorders; Immune System Diseases; Disease; Pathologic Processes; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Bone Marrow Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site