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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

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


- 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.

Inclusion Criteria


- Histologically confirmed advanced solid tumor that is refractory to standard therapy

- 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

- No other concurrent biologic therapy

- No concurrent colony stimulating factors or epoetin alfa for the prevention of


- 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

- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Lionel D. Lewis, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Norris Cotton Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2000

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms



Norris Cotton Cancer Center Lebanon, New Hampshire  03756