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Phase I Study of Batracylin in Patients With Metastatic or Unresectable Solid Tumors or Lymphoma
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
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase I
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Biomarker/Laboratory analysis, Treatment
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Active
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18 and over
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NCI
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NCI-07-C-0097 7859, 07-C-0097, NCT00450502
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Special Category:
NCI Web site featured trial, NIH Clinical Center trial 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.
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
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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 36A total of 36 patients will be accrued for this study. Outcomes Primary Outcome(s)Maximum tolerated dose Dose-limiting toxicity
Secondary Outcome(s)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-Medical Oncology ![](https://webarchive.library.unt.edu/eot2008/20081021090505im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20081021090505im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20081021090505im_/http://www.cancer.gov/images/spacer.gif) | Anthony Murgo, MD, Protocol chair | ![](https://webarchive.library.unt.edu/eot2008/20081021090505im_/http://www.cancer.gov/images/spacer.gif) | | ![](https://webarchive.library.unt.edu/eot2008/20081021090505im_/http://www.cancer.gov/images/spacer.gif) | Trial Sites
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U.S.A. |
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Maryland |
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Bethesda |
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| | | | | | | | Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office |
| | Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office | |
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Related Information Featured Trial Article
Registry Information | ![](https://webarchive.library.unt.edu/eot2008/20081021090505im_/http://www.cancer.gov/images/spacer.gif) | Official Title | | A Phase I Study of Batracylin (NSC 320846) in Subjects with Solid Tumors and Lymphomas | ![](https://webarchive.library.unt.edu/eot2008/20081021090505im_/http://www.cancer.gov/images/spacer.gif) | Trial Start Date | | 2007-03-19 | ![](https://webarchive.library.unt.edu/eot2008/20081021090505im_/http://www.cancer.gov/images/spacer.gif) | Trial Completion Date | | 2008-06-11 (estimated) | ![](https://webarchive.library.unt.edu/eot2008/20081021090505im_/http://www.cancer.gov/images/spacer.gif) | Registered in ClinicalTrials.gov | | NCT00450502 | ![](https://webarchive.library.unt.edu/eot2008/20081021090505im_/http://www.cancer.gov/images/spacer.gif) | Date Submitted to PDQ | | 2007-02-05 | ![](https://webarchive.library.unt.edu/eot2008/20081021090505im_/http://www.cancer.gov/images/spacer.gif) | Information Last Verified | | 2008-04-06 |
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. Back to Top |
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