Status:
COMPLETED
Methoxyamine and Temozolomide in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as methoxyamine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. G...
Detailed Description
OBJECTIVES: * To determine the maximum tolerated dose of methoxyamine given in conjunction with temozolomide in patients with and without CNS disease. * To determine the dose limiting toxicities of t...
Eligibility Criteria
Inclusion
- Patients must have a histologically confirmed solid tumor that is considered incurable and is not amenable to conventional surgical, radiation therapy or chemotherapy treatment programs.
- Prior chemotherapy and/or radiation are allowed. At least 3 weeks must have elapsed since prior large-field radiation therapy; patients must have been off previous anti-cancer therapy for at least 3 weeks (6 weeks for mitomycin-C and nitrosoureas); and recovered from all treatment related toxicity to \< grade 1 according to NCI CTCAE version 3.0 (with the exception of alopecia and radiation-induced taste changes). Prior temozolomide treatment is not restricted.
- ECOG performance status (PS) 0-2 (Karnofsky PS 50-100%)
- Life expectancy ≥ 12 weeks
- Patients must have normal organ and marrow function as defined below:
- Absolute neutrophil count ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Hemoglobin ≥ 10.0 g/dL
- Total bilirubin ≤ 1.5 mg/dL
- AST ≤ 2.5 times upper limit of normal
- Creatinine ≤ 1.5 mg/dL and/or creatinine clearance ≥ 60 mL/min
- Patients with known primary or metastatic CNS disease, are eligible for participation in cohort B, but not in cohort A.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Patients may not be receiving any other investigational agents or have received other investigational agents for at least 3 weeks.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant and lactating women are excluded from this study because the methoxyamine and temozolomide combination is likely to be teratogenic.
- NYHA classification III or IV heart disease
- Patients with known primary or metastatic CNS disease (cohort B) are not eligible if they have a mini mental status exam score \< 15 or evidence of leptomeningeal disease.
- Patients with pre-existing neurologic toxicity \> grade1 (as per CTCAE, version 3.0) are not eligible for participation in cohort A.
- Patients screened for participation in cohort B with pre-existing neurologic toxicity \> grade 2 (as per CTCAE, version 3.0) are not eligible, unless pre-existing neurologic toxicity is documented in detail and patient's participation in the trial has been approved by the neuro-oncology team at participating institutions.
Key Trial Info
Start Date :
August 16 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2017
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00892385
Start Date
August 16 2007
End Date
March 8 2017
Last Update
February 22 2019
Active Locations (1)
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1
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106