NCT00027742

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and interferon alfa in treating patients who have stage III or stage IV melanoma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started May 2001

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2001

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2001

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

4.1 years

First QC Date

December 7, 2001

Last Update Submit

June 4, 2013

Conditions

Intraocular MelanomaMelanoma (Skin)

Keywords

iris melanomaextraocular extension melanomarecurrent intraocular melanomastage III melanomastage IV melanomarecurrent melanoma

Interventions

pegylated interferon alfaBIOLOGICAL
temozolomideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed malignant melanoma * Unresectable stage III or stage IV disease * Ocular, mucosal, or cutaneous melanoma * Measurable disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 150,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT/SGPT no greater than 3 times ULN * Alkaline phosphatase no greater than 3 times ULN Renal: * Creatinine no greater than 1.5 times ULN OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No history of severe cardiovascular disease * No myocardial infarction within the past 6 months * No unstable angina * No New York Heart Association class III or IV heart disease (congestive heart failure) * No ventricular tachyarrhythmias Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No AIDS-related illness * No frequent vomiting or other medical condition that would preclude oral medication intake (e.g., partial bowel obstruction) * No serious infection requiring IV antibiotics * No psychiatric disorder requiring ongoing therapy or medication * No nonmalignant illness or other medical condition that would preclude study * No other active malignancy within the past 2 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or T1a or b prostate cancer detected initially during transurethral resection of the prostate (TURP) (comprising less than 5% of resected tissue) with PSA level normal since TURP PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior biologic therapy or immunotherapy and recovered * No concurrent immunotherapy Chemotherapy: * No prior dacarbazine * No prior temozolomide * No other concurrent chemotherapy Endocrine therapy: * No concurrent systemic corticosteroids Radiotherapy: * At least 3 weeks since prior radiotherapy, interstitial brachytherapy, or radiosurgery * At least 3 weeks since prior radiotherapy to the brain for brain metastases * Prior radiotherapy to indicator lesions allowed if there is evidence of disease progression * Recovered from prior radiotherapy * No concurrent radiotherapy Surgery: * At least 2 weeks since prior surgical procedure requiring general anesthesia and recovered

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

  • Krown SE, Hwu WJ, Menell JH, et al.: A phase II study of temozolomide (TMZ) and pegylated interferon α-2b (PGI) in the treatment of advanced melanoma. [Abstract] J Clin Oncol 22 (Suppl 14): A-7533, 718s, 2004.

    RESULT

MeSH Terms

Conditions

Uveal MelanomaMelanoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsEye NeoplasmsNeoplasms by SiteEye DiseasesUveal DiseasesSkin NeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Wen-Jen Hwu, MD, PhD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2001

First Posted

January 27, 2003

Study Start

May 1, 2001

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

US(1)