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

NCT ID: NCT00272415

Last Updated: 2009-03-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31

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.

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

INO-1001

Intervention Type: DRUG

Intravenous repeating dose

temozolomide

Intervention Type: DRUG

Oral repeating dose

Interventions

INO-1001

Intravenous repeating dose

Intervention Type: DRUG

temozolomide

Oral repeating dose

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Genentech, Inc.

Principal Investigators

Jennifer Low, M.D., Ph.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Other Identifiers

INO4136g

Identifier Type: -

Identifier Source: secondary_id

IPC-06-2004

Identifier Type: -

Identifier Source: org_study_id