Temozolomide Plus PEG-Interferon Alfa-2B in Treating Patients With Advanced Solid Tumors

March 28, 2018 updated by: Lionel.D.Lewis, MD, Dartmouth-Hitchcock Medical Center

A Phase-I Study Of Cyclical Oral Administration Of Temozolomide In Combination With PEG12000-Interferon Alfa-2B In Patients With Refractory And/Or Advanced Solid Tumors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the safety and tolerability of temozolomide and PEG-interferon alfa-2b in patients with advanced refractory solid tumors or chemotherapy-naive advanced cancer.
  • Determine the maximum tolerated dose (MTD) and dose-limiting toxicity of this regimen in this patient population.
  • Determine the pharmacokinetics of PEG-interferon alfa-2b at the MTD when administered with temozolomide in this patient population.
  • Determine the anti-tumor activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oral temozolomide on days 1-7 and 15-21 and PEG-interferon alfa-2b subcutaneously on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-9 patients receive escalating doses of temozolomide and PEG-interferon alfa-2b until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0002
        • Norris Cotton Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Lionel D. Lewis, MD, Norris Cotton Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2000

Primary Completion (Actual)

November 1, 2002

Study Completion (Actual)

November 1, 2002

Study Registration Dates

First Submitted

April 10, 2001

First Submitted That Met QC Criteria

July 29, 2003

First Posted (Estimate)

July 30, 2003

Study Record Updates

Last Update Posted (Actual)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068523
  • P30CA023108 (U.S. NIH Grant/Contract)
  • DMS-0010
  • NCI-G01-1924

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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