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Temozolomide Plus PEG-Interferon Alfa-2B in Treating Patients With Advanced Solid Tumors
This study is ongoing, but not recruiting participants.
First Received: April 10, 2001   Last Updated: February 6, 2009   History of Changes
Sponsor: Norris Cotton Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00014261
  Purpose

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Biological: PEG-interferon alfa-2b
Drug: temozolomide
Phase I

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00014261

Locations
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
Sponsors and Collaborators
Norris Cotton Cancer Center
Investigators
Study Chair: Lionel D. Lewis, MD Norris Cotton Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068523, DMS-0010, NCI-G01-1924
Study First Received: April 10, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00014261     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Interferon-alpha
Anti-Infective Agents
Interferon Type I, Recombinant
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Interferons
Physiological Effects of Drugs
Angiogenesis Inhibitors
Temozolomide
Antiviral Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Peginterferon alfa-2b
Antineoplastic Agents, Alkylating
Growth Inhibitors
Angiogenesis Modulating Agents
Interferon Alfa-2a
Alkylating Agents
Interferon Alfa-2b

ClinicalTrials.gov processed this record on November 09, 2009