- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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New Hampshire
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Lebanon, New Hampshire, Vereinigte Staaten, 03756-0002
- Norris Cotton Cancer Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienstuhl: Lionel D. Lewis, MD, Norris Cotton Cancer Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antiinfektiva
- Antivirale Mittel
- Antineoplastische Mittel
- Immunologische Faktoren
- Antineoplastische Mittel, alkylierend
- Alkylierungsmittel
- Interferone
- Interferon-alpha
- Temozolomid
- Interferon alpha-2
- Peginterferon alfa-2b
Andere Studien-ID-Nummern
- CDR0000068523
- P30CA023108 (US NIH Stipendium/Vertrag)
- DMS-0010
- NCI-G01-1924
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