A Study of Intravenous INO-1001 Plus Oral Temozolomide to Evaluate Tolerability, Safety, and Pharmacokinetics in Patients With Melanoma
- Registration Number
- NCT00272415
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
This is a prospective, open-label, non-randomized, multicenter study in adults, aged eighteen (18) or older, with newly-diagnosed or recurrent unresectable Stage III or Stage IV melanoma. A maximum of 18 subjects will be enrolled in Stage 1 of this study. (Stage 1 completed enrollment in June 2006.) A maximum of 39 subjects will be enrolled in Stage 2 of this study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 39
Inclusion Criteria
- Biopsy proven malignant melanoma with metastasis that is unresectable Stage III or Stage IV. Subjects with recurrent melanoma that is unresectable are also eligible
- Measurable indicator metastases
- Age 18 years or older
- ECOG status 0-2
- An interval at the time of enrollment of at least: a) 2 weeks since surgical resection (if conducted); b) 4 weeks since prior radiotherapy or chemotherapy, and c) 6 weeks since chemotherapy with a nitrosourea
- Hematocrit > 29%, ANC > 1500 cells/ul, platelets > 100,000 cells/ul
- Serum creatinine within the laboratory's upper limit of normal
- Serum AST and ALT ≤ 1.5 x the laboratory's upper limit of normal
- Subject signed informed consent prior to subject entry
Exclusion Criteria
- Female patients who are pregnant or breast-feeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to administration of each cycle of the study drug regimen.
- Subjects of childbearing potential who are not willing or able to use an effective method of contraception, consisting of at least one-barrier method (e.g., condom and diaphragm), for the duration of the study and for at least 3 months after completing the treatment.
- Subjects previously treated with DTIC or TMZ
- Symptomatic central nervous metastases
- Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study.
- Confirmed diagnosis of hepatitis or HIV infection
- Any medical, psychiatric, or social problem that might interfere with the performance, completion, and/or interpretation of the trial
- Patients who have had any surgery within two weeks prior to enrollment in this study, or who have not recovered from the side effects of this or any other therapy
- Patients unwilling to comply with the protocol or who in the judgment of the Principal Investigator are unable to abide by the rules of the protocol
- Subjects who have received a potent CYP3A4 inhibitor or inducer orally or parenterally within approximately 14 days prior to enrollment
- Subjects who have received amiodarone within 30 days of study drug administration
- History of hypersensitivity reaction to more than three (3) drugs or to mannitol
- Patients who have received any investigational study agent within 30 days of Day 1 of Cycle 1
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 temozolomide - 1 INO-1001 -
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) or recommended Phase II dose of INO-1001 to be used in combination with TMZ Length of study Pharmacokinetic (PK) profile of intravenous INO-1001 Length of study Safety and tolerability of combined therapy with oral temozolomide (TMZ) and intravenous INO-1001 Length of study
- Secondary Outcome Measures
Name Time Method Safety of repeat dosing Length of study Pharmacodynamic (PD) activity of intravenous INO-1001 Length of study Response Length of study Progression-free survival Length of study Overall survival Length of study