Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-29 @ 9:38 PM
Study NCT ID:
NCT00014261
Status:
COMPLETED
Last Update Posted:
2018-03-30
First Post:
2001-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Temozolomide Plus PEG-Interferon Alfa-2B in Treating Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C417083', 'term': 'peginterferon alfa-2b'}, {'id': 'D000077204', 'term': 'Temozolomide'}], 'ancestors': [{'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2002-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-28', 'studyFirstSubmitDate': '2001-04-10', 'studyFirstSubmitQcDate': '2003-07-29', 'lastUpdatePostDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-11', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific'], 'conditions': ['Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: Phase I trial to study the effectiveness of combining temozolomide and PEG-interferon alfa-2B in treating patients who have advanced solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the safety and tolerability of temozolomide and PEG-interferon alfa-2b in patients with advanced refractory solid tumors or chemotherapy-naive advanced cancer.\n* Determine the maximum tolerated dose (MTD) and dose-limiting toxicity of this regimen in this patient population.\n* Determine the pharmacokinetics of PEG-interferon alfa-2b at the MTD when administered with temozolomide in this patient population.\n* Determine the anti-tumor activity of this regimen in these patients.\n\nOUTLINE: This is a dose-escalation study.\n\nPatients 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.\n\nCohorts 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.\n\nPROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed advanced solid tumor that is refractory to standard therapy OR\n* Histologically confirmed chemotherapy-naive advanced cancer for which no curative therapy or higher priority palliative chemotherapy exists\n* Brain metastasis allowed\n* No bone marrow involvement of tumor\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Absolute neutrophil count greater than 1,500/mm\\^3 AND/OR\n* Platelet count greater than 100,000/mm\\^3\n\nHepatic:\n\n* ALT or AST less than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)\n* No autoimmune hepatitis\n\nRenal:\n\n* Creatinine less than 2.5 times ULN\n\nCardiovascular:\n\n* No severe coronary artery disease\n* No congestive heart failure\n\nPulmonary:\n\n* No severe chronic obstructive pulmonary disease\n\nGastrointestinal:\n\n* No frequent vomiting\n* No medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction, partial intestinal bypass, or external biliary diversion)\n\nOther:\n\n* 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\n* No known or suspected hypersensitivity to imidazotetrazin, interferon alfa, or any excipient or vehicle included in the formulation or delivery system of study drug\n* No history of autoimmune disease\n* No preexisting severe psychiatric condition or history of severe psychiatric disorder (including suicidal ideation or attempt)\n* No life-threatening condition or severe preexisting condition\n* No uncontrolled thyroid abnormalities\n* No nonmalignant systemic disease\n* No active uncontrolled infection\n* HIV negative\n* No AIDS-related illness\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 3 weeks since prior biologic agents (e.g., bi-specific antibodies, interleukin-2, or interferon) and recovered (excluding alopecia)\n* No prior allogeneic, syngeneic, or autologous bone marrow or stem cell transplantation\n* No other concurrent biologic therapy\n* No concurrent colony stimulating factors or epoetin alfa for the prevention of myelotoxicity\n\nChemotherapy:\n\n* See Disease Characteristics\n* At least 4 weeks since prior chemotherapy (more than 6 weeks for nitrosoureas, melphalan, or mitomycin) and recovered (excluding alopecia)\n* No prior high-dose chemotherapy and stem cell transplantation\n* No more than 3 prior chemotherapy regimens\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* At least 6 weeks since prior wide-field radiotherapy to at least 25% of bone marrow (e.g., pelvic radiotherapy)\n* More than 6 weeks since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium\n* Recovered from prior radiotherapy (excluding alopecia)\n* No concurrent radiotherapy\n\nSurgery:\n\n* At least 4 weeks since prior major surgery\n* At least 1 week since prior minor surgery\n\nOther:\n\n* At least 4 weeks since prior investigational therapy'}, 'identificationModule': {'nctId': 'NCT00014261', 'briefTitle': 'Temozolomide Plus PEG-Interferon Alfa-2B in Treating Patients With Advanced Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CDR0000068523'}, 'secondaryIdInfos': [{'id': 'P30CA023108', 'link': 'https://reporter.nih.gov/quickSearch/P30CA023108', 'type': 'NIH'}, {'id': 'DMS-0010'}, {'id': 'NCI-G01-1924'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'PEG-interferon alfa-2b', 'type': 'BIOLOGICAL'}, {'name': 'temozolomide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756-0002', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Norris Cotton Cancer Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'overallOfficials': [{'name': 'Lionel D. Lewis, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Norris Cotton Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine and of Pharmacology and Toxicology', 'investigatorFullName': 'Lionel.D.Lewis, MD', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}