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Trial record 29 of 295 for:    IFNA2 AND PEG-interferon alfa-2b

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

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: NCT00014261
Recruitment Status : Completed
First Posted : July 30, 2003
Last Update Posted : March 30, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Lionel.D.Lewis, MD, Dartmouth-Hitchcock Medical Center

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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Biological: PEG-interferon alfa-2b Drug: temozolomide Phase 1

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 2000
Actual Primary Completion Date : November 2002
Actual Study Completion Date : November 2002

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Absolute neutrophil count greater than 1,500/mm^3 AND/OR
  • Platelet count greater than 100,000/mm^3


  • ALT or AST less than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
  • No autoimmune hepatitis


  • Creatinine less than 2.5 times ULN


  • No severe coronary artery disease
  • No congestive heart failure


  • No severe chronic obstructive pulmonary disease


  • 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)


  • 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


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


  • 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


  • 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


  • At least 4 weeks since prior major surgery
  • At least 1 week since prior minor surgery


  • At least 4 weeks since prior investigational therapy

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): NCT00014261

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United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
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Study Chair: Lionel D. Lewis, MD Norris Cotton Cancer Center

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Responsible Party: Lionel.D.Lewis, MD, Professor of Medicine and of Pharmacology and Toxicology, Dartmouth-Hitchcock Medical Center Identifier: NCT00014261     History of Changes
Other Study ID Numbers: CDR0000068523
P30CA023108 ( U.S. NIH Grant/Contract )
First Posted: July 30, 2003    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Keywords provided by Lionel.D.Lewis, MD, Dartmouth-Hitchcock Medical Center:
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Interferon alpha-2
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs