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A Phase I Clinical And Pharmacological Study Of Pyroxamide (NSC 696085) In Patients With Advanced Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Precancerous Condition, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Clinical And Pharmacological Study Of Pyroxamide (NSC 696085) In Patients With Advanced Malignancies


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Leonard B. Saltz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

99-090

NCT ID:

NCT00042900

Start Date:

April 2002

Completion Date:

September 2002

Related Keywords:

  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Precancerous Condition
  • Small Intestine Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • 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
  • recurrent adult acute myeloid leukemia
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • refractory chronic lymphocytic leukemia
  • refractory hairy cell leukemia
  • refractory multiple myeloma
  • relapsing chronic myelogenous leukemia
  • secondary acute myeloid leukemia
  • secondary myelodysplastic syndromes
  • small intestine lymphoma
  • stage III adult Hodgkin lymphoma
  • stage III adult T-cell leukemia/lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult Burkitt lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III chronic lymphocytic leukemia
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III mantle cell lymphoma
  • stage III multiple myeloma
  • stage III mycosis fungoides/Sezary syndrome
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult Burkitt lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV chronic lymphocytic leukemia
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV mantle cell lymphoma
  • stage IV mycosis fungoides/Sezary syndrome
  • untreated adult acute lymphoblastic leukemia
  • untreated adult acute myeloid leukemia
  • untreated hairy cell leukemia
  • stage IV adult Hodgkin lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • unspecified adult solid tumor, protocol specific
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Precancerous Conditions
  • Lymphoma, Large-Cell, Immunoblastic
  • Duodenal Neoplasms
  • Ileal Neoplasms
  • Jejunal Neoplasms
  • Intestinal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021