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Batracylin in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2009
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00450502
  Purpose

RATIONALE: Drugs used in chemotherapy, such as batracylin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I trial is studying the side effects and best dose of batracylin in treating patients with metastatic or unresectable solid tumors or lymphoma.


Condition Intervention Phase
Lymphoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: daniquidone
Procedure: pharmacological study
Phase I

MedlinePlus related topics: Cancer Hodgkin's Disease Intestinal Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma
Drug Information available for: Batracylin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Study of Batracylin (NSC 320846) in Subjects With Solid Tumors and Lymphomas

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose [ Designated as safety issue: Yes ]
  • Dose-limiting toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: March 2007
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of batracylin in patients with metastatic or unresectable solid tumors or lymphoma who have a slow acetylator NAT-2 genotype.
  • Determine the dose-limiting toxicities and toxicity profile of this regimen in these patients.

Secondary

  • Assess, preliminarily, the antitumor activity of this regimen in these patients.
  • Correlate polymorphisms in patients with slow acetylator NAT-2 genotypes (NAT-2*5, NAT-2*6, NAT-2*7, and NAT-2*14) with pharmacokinetics results.
  • Determine the pharmacokinetics of this regimen.
  • Evaluate the interpatient variability and toxicity ratio.

OUTLINE: This is a dose-escalation study.

Patients receive oral batracylin on days 1-7. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-6 patients receive escalating doses of batracylin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Peripheral blood samples are collected on days 1, 3, and 7 of the first course and on day 1 of subsequent courses for pharmacokinetic and other research studies.

After completion of study treatment, patients are followed for 4 weeks.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumors or lymphoma

    • Metastatic or unresectable disease
  • Measurable or evaluable disease
  • Standard curative measures do not exist or are associated with minimal patient survival benefit
  • Must have a slow acetylator NAT-2 genotype, defined as NAT-2*5, NAT-2*6, NAT-2*7, or NAT-2*14
  • No known brain metastases, except for brain metastases that have remained stable for ≥ 6 months after treatment and that do not require steroids or antiseizure medications

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Life expectancy > 3 months
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ 2.5 mg/dL in patients with Gilbert's syndrome)
  • AST and ALT ≤ 2.5 times ULN
  • Creatinine < 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception before, during, and for 2 months after completion of study treatment
  • No clinically significant illnesses including, but not limited to, any of the following:

    • Active or uncontrolled infection
    • Immune deficiencies
    • Confirmed HIV infection
    • Hepatitis B or hepatitis C
    • Uncontrolled diabetes
    • Uncontrolled hypertension
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Myocardial infarction within the past 6 months
    • Uncontrolled cardiac arrhythmia
    • Psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

  • Recovered from all prior therapy
  • At least 2 weeks since prior batracylin used in an exploratory IND/phase 0 study
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin C, or 7-hydroxystaurosporine)
  • More than 4 weeks since prior biologic therapy
  • At least 1 month since prior radiation therapy or major surgery
  • No other concurrent investigational agents
  • No concurrent protease inhibitors
  • Concurrent bisphosphonates for any cancer allowed
  • Concurrent androgen-deprivation therapy for prostate cancer allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00450502

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center     888-NCI-1937        
Sponsors and Collaborators
Investigators
Principal Investigator: Anthony J. Murgo, MD National Cancer Institute (NCI)
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
Featured Trial Article  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000536009, NCI-07-C-0097
Study First Received: March 20, 2007
Last Updated: January 9, 2009
ClinicalTrials.gov Identifier: NCT00450502  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
intraocular lymphoma
nodal marginal zone B-cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult T-cell leukemia/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 marginal zone lymphoma
recurrent small lymphocytic lymphoma
small intestine lymphoma
splenic marginal zone lymphoma
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult Hodgkin lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma

Study placed in the following topic categories:
Lymphoma, Mantle-Cell
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Ileal Diseases
Lymphoma, large-cell, immunoblastic
Duodenal Neoplasms
Lymphomatoid granulomatosis
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large-Cell, Anaplastic
Hodgkin Disease
Chronic lymphocytic leukemia
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Digestive System Neoplasms
Leukemia, B-cell, chronic
Waldenstrom Macroglobulinemia
B-cell lymphomas
Leukemia, T-Cell
Gastrointestinal Neoplasms
Anaplastic large cell lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Cutaneous
Hodgkin's disease
Gastrointestinal Diseases
Cutaneous T-cell lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Lymphoma, B-Cell
Lymphoma, large-cell
Burkitt's lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Immune System Diseases
Jejunal Diseases

ClinicalTrials.gov processed this record on January 14, 2009