Melanoma
Conditions
Keywords
INO4136g, inotek, Parp, Temodar
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.
Interventions
DRUGINO-1001
Intravenous repeating dose
DRUGtemozolomide
Oral repeating dose
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Progression-free survival | Length of study |
| Safety of repeat dosing | Length of study |
| Overall survival | Length of study |
| Pharmacodynamic (PD) activity of intravenous INO-1001 | Length of study |
| Response | Length of study |
Outcome results
None listed