Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-31 @ 7:59 PM
Study NCT ID:
NCT00003993
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D016400', 'term': 'Lymphoma, Large-Cell, Immunoblastic'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D054218', 'term': 'Precursor T-Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D064090', 'term': 'Intraocular Lymphoma'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D007119', 'term': 'Immunoblastic Lymphadenopathy'}, {'id': 'D017728', 'term': 'Lymphoma, Large-Cell, Anaplastic'}, {'id': 'D009182', 'term': 'Mycosis Fungoides'}, {'id': 'D012751', 'term': 'Sezary Syndrome'}, {'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D000072281', 'term': 'Lymphadenopathy'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C082598', 'term': 'aldesleukin'}, {'id': 'C046785', 'term': 'bryostatin 1'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-09'}, 'statusVerifiedDate': '2006-05', 'lastUpdateSubmitDate': '2015-04-28', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage IV adult Hodgkin lymphoma', 'recurrent adult Hodgkin lymphoma', 'stage IV cutaneous T-cell non-Hodgkin lymphoma', 'recurrent cutaneous T-cell non-Hodgkin lymphoma', 'small intestine lymphoma', 'unspecified adult solid tumor, protocol specific', 'stage IV grade 1 follicular lymphoma', 'stage IV grade 2 follicular lymphoma', 'stage IV grade 3 follicular lymphoma', 'stage IV adult diffuse small cleaved cell lymphoma', 'stage IV adult diffuse mixed cell lymphoma', 'stage IV adult diffuse large cell lymphoma', 'stage IV adult immunoblastic large cell lymphoma', 'stage IV adult lymphoblastic lymphoma', 'stage IV adult Burkitt lymphoma', 'recurrent grade 1 follicular lymphoma', 'recurrent grade 2 follicular lymphoma', 'recurrent grade 3 follicular lymphoma', 'recurrent adult diffuse small cleaved cell lymphoma', 'recurrent adult diffuse mixed cell lymphoma', 'recurrent adult diffuse large cell lymphoma', 'recurrent adult immunoblastic large cell lymphoma', 'recurrent adult lymphoblastic lymphoma', 'recurrent adult Burkitt lymphoma', 'stage IV adult T-cell leukemia/lymphoma', 'recurrent adult T-cell leukemia/lymphoma', 'primary central nervous system non-Hodgkin lymphoma', 'intraocular lymphoma', 'stage IV mantle cell lymphoma', 'recurrent mantle cell lymphoma', 'angioimmunoblastic T-cell lymphoma', 'anaplastic large cell lymphoma', 'stage IV mycosis fungoides/Sezary syndrome', 'recurrent mycosis fungoides/Sezary syndrome', 'recurrent marginal zone lymphoma', 'recurrent small lymphocytic lymphoma', 'stage IV small lymphocytic lymphoma', 'stage IV marginal zone lymphoma', 'extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue', 'nodal marginal zone B-cell lymphoma', 'splenic marginal zone lymphoma'], 'conditions': ['Lymphoma', 'Small Intestine Cancer', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': "RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining chemotherapy and interleukin-2 may kill more cancer cells.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of interleukin-2 when given together with bryostatin 1 in treating patients with refractory solid tumors or lymphoma.", 'detailedDescription': 'OBJECTIVES:\n\n* Determine the safety and side effects of bryostatin 1 and interleukin-2 in patients with refractory solid tumors or lymphomas.\n* Determine the maximum tolerated dose for interleukin-2 with bryostatin 1 in these patients.\n* Determine whether bryostatin 1 and interleukin-2 increase the expression of recognition and costimulatory molecules on human monocytes and their ability to act as antigen presenting cells.\n* Assess any anti-tumor response in these patients treated with this regimen.\n\nOUTLINE: This is a dose escalation study of interleukin-2.\n\nPatients receive bryostatin 1 IV over 24 hours on days 1 and 8, and interleukin-2 subcutaneously on days 1-5 and days 8-12. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 3-6 patients receive escalating doses of interleukin-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.\n\nPROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study in less than 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically proven solid tumor or lymphoma that is not curable by surgery, radiotherapy, or standard chemotherapy, or for which no curative therapy exists\n* Prostate cancer patients must have the following:\n\n * Tumor progression following blockade of both testicular and adrenal androgens\n * Serum testosterone in the castrate range (less than 20 ng/mL)\n * At least 3 months since prior suramin therapy\n * At least 4 weeks since prior flutamide or other antiandrogen medication and no evidence of response to treatment\n * Luprolide should continue if no prior orchiectomy\n* No prior or concurrent brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0 or 1\n\nLife expectancy:\n\n* At least 3 months\n\nHematopoietic:\n\n* WBC at least 3,500/mm\\^3 OR\n* Granulocyte count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 8 g/dL\n\nHepatic:\n\n* Hepatitis B surface antigen negative\n* PT no greater than 14 seconds\n* PTT no greater than 35 seconds\n* Bilirubin no greater than 1.5 mg/dL unless due to Gilbert's disease\n* SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN)\n* Alkaline phosphatase no greater than 2.5 times ULN\n* Albumin at least 2.5 g/dL\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL OR\n* Creatinine clearance at least 50 mL/min\n* Corrected calcium at least 8.0 mg/dL, but no greater than 10.7 mg/dL\n\nCardiovascular:\n\n* No prior myocardial infarction, coronary artery disease (CAD), congestive heart failure, second or third degree AV block, or cardiac arrhythmias requiring treatment\n* No evidence of CAD on EKG\n\nPulmonary:\n\n* FEV1-1 at least 70% predicted\n* DLCO at least 60% predicted\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* HIV negative\n* At least 1 week since active infection requiring antibiotics\n* No other medical or psychiatric condition that would preclude study\n* No prior or concurrent seizure disorders controlled with medication\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 4 weeks since prior interleukin-2\n* At least 4 weeks since other prior biologic therapy for solid tumors or lymphomas\n\nChemotherapy:\n\n* See Disease Characteristics\n* At least 4 weeks since prior bryostatin 1\n* At least 4 weeks since other prior chemotherapy for solid tumors or lymphomas\n\nEndocrine therapy:\n\n* See Disease Characteristics\n* At least 4 weeks since other prior endocrine therapy for solid tumors or lymphomas\n* No absolute requirement for corticosteroids\n\nRadiotherapy:\n\n* See Disease Characteristics\n* At least 4 weeks since prior radiotherapy for solid tumors or lymphomas\n\nSurgery:\n\n* See Disease Characteristics\n* At least 4 weeks since prior surgery for solid tumors or lymphomas\n\nOther:\n\n* No absolute requirement for nonsteroidal anti-inflammatory drugs or H2 blockers"}, 'identificationModule': {'nctId': 'NCT00003993', 'briefTitle': 'Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase lb Trial of the Combination of Bryostatin-1 and Low Dose Interleukin-2: Evaluation of the Functional and Molecular Status of Human Monocytes as Antigen Presenting Cells', 'orgStudyIdInfo': {'id': 'CDR0000067198'}, 'secondaryIdInfos': [{'id': 'NCI-T99-0015'}, {'id': 'LSUMC-9901'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'aldesleukin', 'type': 'BIOLOGICAL'}, {'name': 'bryostatin 1', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224-6825', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institute on Aging - Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Igor Espinoza-Delgado, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Gerontology Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}