Status:
TERMINATED
A Study of Intravenous INO-1001 Plus Oral Temozolomide to Evaluate Tolerability, Safety, and Pharmacokinetics in Patients With Melanoma
Lead Sponsor:
Genentech, Inc.
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00272415
Start Date
October 1 2005
Last Update
March 11 2009
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