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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00272415
Recruitment Status : Terminated
First Posted : January 6, 2006
Last Update Posted : March 11, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Melanoma Drug: INO-1001 Drug: temozolomide Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib, Open-Label, Multicenter Trial of Intravenous INO-1001 Plus Oral Temozolomide to Evaluate the Tolerability, Safety, and Pharmacokinetics in Subjects With Newly-Diagnosed or Recurrent Unresectable Stage III or Stage IV Melanoma
Study Start Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: INO-1001
Intravenous repeating dose
Drug: temozolomide
Oral repeating dose

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) or recommended Phase II dose of INO-1001 to be used in combination with TMZ [ Time Frame: Length of study ]
  2. Pharmacokinetic (PK) profile of intravenous INO-1001 [ Time Frame: Length of study ]
  3. Safety and tolerability of combined therapy with oral temozolomide (TMZ) and intravenous INO-1001 [ Time Frame: Length of study ]

Secondary Outcome Measures :
  1. Safety of repeat dosing [ Time Frame: Length of study ]
  2. Pharmacodynamic (PD) activity of intravenous INO-1001 [ Time Frame: Length of study ]
  3. Response [ Time Frame: Length of study ]
  4. Progression-free survival [ Time Frame: Length of study ]
  5. Overall survival [ Time Frame: Length of study ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00272415

Sponsors and Collaborators
Genentech, Inc.
Study Director: Jennifer Low, M.D., Ph.D. Genentech, Inc.

Responsible Party: Clinical Trials Posting Group, Genentech, Inc. Identifier: NCT00272415     History of Changes
Other Study ID Numbers: IPC-06-2004
First Posted: January 6, 2006    Key Record Dates
Last Update Posted: March 11, 2009
Last Verified: November 2007

Keywords provided by Genentech, Inc.:

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents