Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Batracylin in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Biomarker/Laboratory analysis, Treatment	Active	18 and over	NCI	NCI-07-C-0097 7859, 07-C-0097, NCT00450502

Special Category: NCI Web site featured trial, NIH Clinical Center trial

Objectives

Primary

1. 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.
2. Determine the dose-limiting toxicities and toxicity profile of this regimen in these patients.

Secondary

1. Assess, preliminarily, the antitumor activity of this regimen in these patients.
2. 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.
3. Determine the pharmacokinetics of this regimen.
4. Evaluate the interpatient variability and toxicity ratio.

Entry 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

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

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

Expected Enrollment

A total of 52 patients will be accrued for this study.

Outcomes

Maximum tolerated dose
Dose-limiting toxicity

Pharmacokinetics

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.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Shivaani Kummar, MD, Principal investigator		Ph: 301-435-5402 Email: kummars@mail.nih.gov

U.S.A.
Maryland
	Bethesda
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
		Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office	Ph:  888-NCI-1937

Related Information

Featured Trial Article

Registry Information
Official Title		A Phase I Study of Batracylin (NSC 320846) in Subjects with Solid Tumors and Lymphomas
Trial Start Date		2007-03-19
Trial Completion Date		2008-06-11 (estimated)
Registered in ClinicalTrials.gov		NCT00450502
Date Submitted to PDQ		2007-02-05
Information Last Verified		2009-06-14

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