NCT00014261

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PEG-interferon alfa-2B may interfere with the growth of cancer cells. Combining temozolomide with PEG-interferon alfa-2B may be an effective treatment for advanced solid tumors. PURPOSE: Phase I trial to study the effectiveness of combining temozolomide and PEG-interferon alfa-2B in treating patients who have advanced solid tumors.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 2000

Typical duration for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2001

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
9 months until next milestone

First Posted

Study publicly available on registry

July 30, 2003

Completed
Last Updated

March 30, 2018

Status Verified

March 1, 2018

Enrollment Period

2.1 years

First QC Date

April 10, 2001

Last Update Submit

March 28, 2018

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

PEG-interferon alfa-2bBIOLOGICAL
temozolomideDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed advanced solid tumor that is refractory to standard therapy OR * Histologically confirmed chemotherapy-naive advanced cancer for which no curative therapy or higher priority palliative chemotherapy exists * Brain metastasis allowed * No bone marrow involvement of tumor PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1,500/mm\^3 AND/OR * Platelet count greater than 100,000/mm\^3 Hepatic: * ALT or AST less than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present) * No autoimmune hepatitis Renal: * Creatinine less than 2.5 times ULN Cardiovascular: * No severe coronary artery disease * No congestive heart failure Pulmonary: * No severe chronic obstructive pulmonary disease Gastrointestinal: * No frequent vomiting * No medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction, partial intestinal bypass, or external biliary diversion) Other: * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No known or suspected hypersensitivity to imidazotetrazin, interferon alfa, or any excipient or vehicle included in the formulation or delivery system of study drug * No history of autoimmune disease * No preexisting severe psychiatric condition or history of severe psychiatric disorder (including suicidal ideation or attempt) * No life-threatening condition or severe preexisting condition * No uncontrolled thyroid abnormalities * No nonmalignant systemic disease * No active uncontrolled infection * HIV negative * No AIDS-related illness * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior biologic agents (e.g., bi-specific antibodies, interleukin-2, or interferon) and recovered (excluding alopecia) * No prior allogeneic, syngeneic, or autologous bone marrow or stem cell transplantation * No other concurrent biologic therapy * No concurrent colony stimulating factors or epoetin alfa for the prevention of myelotoxicity Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy (more than 6 weeks for nitrosoureas, melphalan, or mitomycin) and recovered (excluding alopecia) * No prior high-dose chemotherapy and stem cell transplantation * No more than 3 prior chemotherapy regimens * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * At least 6 weeks since prior wide-field radiotherapy to at least 25% of bone marrow (e.g., pelvic radiotherapy) * More than 6 weeks since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium * Recovered from prior radiotherapy (excluding alopecia) * No concurrent radiotherapy Surgery: * At least 4 weeks since prior major surgery * At least 1 week since prior minor surgery Other: * At least 4 weeks since prior investigational therapy

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

Sponsors & Collaborators

Study Sites (1)

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756-0002, United States

Location

MeSH Terms

Interventions

peginterferon alfa-2bTemozolomide

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Lionel D. Lewis, MD

    Norris Cotton Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and of Pharmacology and Toxicology

Study Record Dates

First Submitted

April 10, 2001

First Posted

July 30, 2003

Study Start

October 1, 2000

Primary Completion

November 1, 2002

Study Completion

November 1, 2002

Last Updated

March 30, 2018

Record last verified: 2018-03

Locations

US(1)