A Study of Intravenous INO-1001 Plus Oral Temozolomide to Evaluate Tolerability, Safety, and Pharmacokinetics in Patients With Melanoma

Genentech

Status and phase

Terminated

Phase 1

Conditions

Melanoma

Treatments

Drug: temozolomide

Drug: INO-1001

Study type

Interventional

Funder types

Industry

Identifiers

NCT00272415

INO4136g

IPC-06-2004

Details and patient eligibility

About

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.

Enrollment

39 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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