- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00014261
Temozolomide Plus PEG-Interferon Alfa-2B in Treating Patients With Advanced Solid Tumors
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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New Hampshire
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Lebanon, New Hampshire, États-Unis, 03756-0002
- Norris Cotton Cancer Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Lionel D. Lewis, MD, Norris Cotton Cancer Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Tumeurs
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-infectieux
- Agents antiviraux
- Agents antinéoplasiques
- Facteurs immunologiques
- Agents antinéoplasiques, alkylants
- Agents d'alkylation
- Interférons
- Interféron-alpha
- Témozolomide
- Interféron alpha-2
- Peginterféron alfa-2b
Autres numéros d'identification d'étude
- CDR0000068523
- P30CA023108 (Subvention/contrat des NIH des États-Unis)
- DMS-0010
- NCI-G01-1924
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