NCT00272415

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2006

Completed
Last Updated

March 11, 2009

Status Verified

November 1, 2007

First QC Date

January 3, 2006

Last Update Submit

March 9, 2009

Conditions

Melanoma

Keywords

INO4136ginotekParpTemodar

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Safety of repeat dosing

    Length of study

  • Pharmacodynamic (PD) activity of intravenous INO-1001

    Length of study

  • Response

    Length of study

  • Progression-free survival

    Length of study

  • Overall survival

    Length of study

Study Arms (1)

1

EXPERIMENTAL
Drug: INO-1001Drug: temozolomide

Interventions

INO-1001DRUG

Intravenous repeating dose

1
temozolomideDRUG

Oral repeating dose

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

MelanomaDeafness, Autosomal Recessive 53

Interventions

INO 1001Temozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jennifer Low, M.D., Ph.D.

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 3, 2006

First Posted

January 6, 2006

Study Start

October 1, 2005

Last Updated

March 11, 2009

Record last verified: 2007-11