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Pyroxamide in Treating Patients With Advanced Cancer
This study has been completed.
Study NCT00042900   Information provided by National Cancer Institute (NCI)
First Received: August 5, 2002   Last Updated: November 16, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

August 5, 2002
November 16, 2008
April 2002
 
 
Complete list of historical versions of study NCT00042900 on ClinicalTrials.gov Archive Site
 
 
 
Pyroxamide in Treating Patients With Advanced Cancer
A Phase I Clinical And Pharmacological Study Of Pyroxamide (NSC 696085) In Patients With Advanced Malignancies

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.

Phase I
Interventional
Treatment
  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Precancerous/Nonmalignant Condition
  • Small Intestine Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
Drug: pyroxamide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
18 Years and older
No
 
United States
 
 
NCT00042900
 
MSKCC-99090, NCI-2110
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Leonard B. Saltz, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
May 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.