Batracylin in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphoma
|Phase I||Biomarker/Laboratory analysis, Treatment||Closed||18 and over||NCI||NCI-07-C-0097|
7859, 07-C-0097, NCT00450502
Special Category: NCI Web site featured trial
- 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.
- 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.
- 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
- 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
- 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
A total of 52 patients will be accrued for this study.
Maximum tolerated dose
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. Urine samples are also collected on days 1-3, and 7 of course 1 for pharmacokinetic studies.
After completion of study treatment, patients are followed up for 4 weeks.
Trial Lead Organizations
NCI - Center for Cancer Research
|Shivaani Kummar, MD, Principal investigator|
|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|
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.