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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy After Allogeneic Stem Cell Transplantation in Treating Patients With Persistent or Progressive Cancer  Monoclonal Antibody Therapy After Allogeneic Stem Cell Transplantation in Treating Patients With Persistent or Progressive Cancer
Monoclonal Antibody Therapy After Allogeneic Stem Cell Transplantation in Treating Patients With Persistent or Progressive Cancer
For Condition: Breast Cancer,Endocrine Cancer,hematopoietic and lymphoid cancer,Neuroblastoma,female reproductive cancer
Status: Recruiting
Sponsor(s): University of California, San Diego , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy after allogeneic stem cell transplantation in treating patients who have persistent or progressive cancer.
Details: OBJECTIVES: - Determine the optimal safe dose, in terms of incidence of grade 3 or 4 graft-versus-host disease, of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody administered to patients with persistent or progressive malignancies after allogeneic hematopoietic stem cell transplantation. - Determine the pharmacokinetics of this drug in these patients. - Determine the best dosing regimen of this drug when administered with donor lymphocyte infusions in these patients. - Determine, preliminarily, the efficacy of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes. Cohorts of 3-6 patients receive escalating doses of MDX-010 until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients with persistent or progressive disease at 60 days after MDX-010 administration and no evidence of graft-versus-host disease receive donor lymphocyte infusions every 60 days for a total of 3 infusions. Patients are followed at 6, 9, and 12 months and then annually thereafter. PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study within 24-30 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 14 Years/71 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of persistent or progressive hematologic malignancy or solid tumor after allogeneic hematopoietic stem cell transplantation (AHSCT) - Persistent or progressive disease demonstrated between post-transplantation day 90 and 3 years after withdrawal of immunosuppressive therapy - The following malignancies are eligible: - Chronic myelogenous leukemia (CML) that meets any of the following criteria: - Cytogenetic progression evidenced by an increase in the percentage of Philadelphia chromosome (Ph)1-positive metaphases (or Ph1-positive cells by fluorescent in situ hybridization) from complete cytogenetic response (CCR) (0% Ph1-positive cells) to partial response (PR) (1-34% Ph1-positive cells); PR to minor response (MR) (35-94% Ph1-positive cells); or MR to no response (95-100% Ph1-positive cells) - Molecular progression evidenced by polymerase chain reaction (PCR) positivity in previously PCR-negative patients (more than 6 months after AHSCT) OR increasing titer of BCR-ABL transcript by quantitative PCR - Cytogenetic persistence evidenced by any Ph1-positive metaphases in bone marrow after day 90 post-AHSCT - Molecular persistence evidenced by PCR positivity (at least 2 separate analyses) by day 180 or later after AHSCT - Myeloproliferative disorder (non-CML) (myelofibrosis with myeloid metaplasia, polycythemia vera, essential thrombocythemia, or chronic myelomonocytic leukemia) that meets any of the following criteria: - Clinical progression evidenced by recurrence of clinical features of malignancy after complete resolution or greater than 25% increase in measurable or evaluable clinical features at least 3 months after AHSCT - Cytogenetic recurrence evidenced by recurrence of clonal cytogenetic or molecular abnormalities at least 6 months after AHSCT - Clinical persistence evidenced by failure of resolution of clinical features clearly attributable to malignancy at least 6 months after AHSCT - Cytogenetic persistence evidenced by persistence of clonal cytogenetic or molecular abnormalities at least 6 months after AHSCT - Acute myeloid leukemia (AML) or acute lymphoblastic leukemia that meets any of the following criteria: - Hematologic relapse by standard criteria - Molecular relapse evidenced by 2 positive PCRs in a patient with a prior negative PCR after AHSCT* - Hematologic persistence evidenced by bone marrow blasts greater than 10% after day 30 post-AHSCT - Molecular persistence evidenced by positive PCR at day 90 or later after AHSCT* NOTE: *PCR will not be used for disease status assessment in AML patients with t(8;21) - Myelodysplastic syndromes that meet any of the following criteria: - Hematologic relapse by standard criteria - Cytogenetic relapse evidenced by recurrence of clonal abnormality in patients who achieved CCR after AHSCT - Hematologic persistence evidenced by cytopenias not attributable to other post-transplant causes accompanied by characteristic morphological changes more than 90 days after AHSCT - Cytogenetic persistence evidenced by persistence of clonal abnormality more than 90 days after AHSCT - Chronic lymphocytic leukemia that meets any of the following criteria: - Greater than 25% increase in absolute lymphocytosis of greater than 5,000/mm^3 - Greater than 25% increase in measurable lymphadenopathy - Persistence of absolute lymphocytosis of greater than 5,000/mm^3 at day 90 or later after AHSCT - Persistence of lymphadenopathy of at least 3 cm in diameter at day 90 or later after AHSCT - Non-Hodgkin's lymphoma, Hodgkin's lymphoma, OR solid tumor that meets any of the following criteria: - Greater than 25% increase in measurable or evaluable disease - Persistence of measurable lesions greater than 3 cm in diameter at day 90 or later after AHSCT - Multiple myeloma that meets any of the following criteria: - Greater than 25% increase in paraprotein band, abnormal quantitative immunoglobulin level, or urine protein excretion - Greater than 25% increase in percent of plasma cells in the bone marrow (if greater than 15%) - Presence of new lytic bone lesions - Persistence of paraprotein band, abnormally elevated quantitative immunoglobulin level, or bone marrow plasmacytosis greater than 15% for a period of at least 90 days after AHSCT - Measurable or evaluable disease - At least 1 bidimensionally measurable lesion at least 1.5 cm in diameter - Evaluable disease is defined as disease that is assessable for response (e.g., pleural effusion, elevated serum tumor) - Leukemia is considered evaluable disease - At least 50% donor chimerism in the T-cell lineage OR full (greater than 90%) donor chimerism in unseparated blood on last assessment within 3 months before treatment on study begins - No evidence on consecutive testing of greater than 10% decline in T-cell chimerism beyond the error of the test PATIENT CHARACTERISTICS: Age - 14 to 71 Performance status - ECOG 0-2 Life expectancy - More than 3 months Hematopoietic - See Disease Characteristics - Absolute lymphocyte count greater than 500/mm^3 Hepatic - Bilirubin no greater than 2.0 mg/dL* - AST and ALT no greater than 3 times upper limit of normal* - Chronic hepatitis B or C infection allowed provided other hepatic function criteria are met NOTE: *Unless compromised organ function can be attributed to the malignancy Renal - Creatinine no greater than 2.0 mg/dL (unless compromised organ function can be attributed to the malignancy) Cardiovascular - No symptomatic cardiac disease (unless compromised organ function can be attributed to the malignancy) Pulmonary - No symptomatic pulmonary disease (unless compromised organ function can be attributed to the malignancy) Immunologic - No concurrent autoimmune diseases requiring the chronic use of immunosuppressive medications - Active connective tissue disease - CNS disease including multiple sclerosis or demyelinating disease - Inflammatory bowel disease - Autoimmune hepatitis - No ongoing serious infection - No known history of HIV Other - Not pregnant or nursing - Fertile patients must use effective contraception during and for at least 4 months after study therapy - No prior grade 3 or 4 acute GVHD - No other serious ongoing medical condition that would preclude study therapy - No other malignancy within the past 5 years - No psychological or psychiatric condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - At least 6 weeks since prior immunosuppressive agents - No concurrent immunosuppressive agents for clinically active graft-versus-host disease (GVHD) - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AsadBashey, Study Chair, University of California, San Diego
Green Cancer Center at Scripps Clinic *Recruiting*
La Jolla, California, 92037-1027
United States
Recruiting James Mason 858-554-8597
University of California San Diego *Recruiting*
La Jolla, California, 92093-0960
United States
Recruiting Asad Bashey 858-657-6790
Additional Information:
Study ID Numbers: CDR0000301644; NCI-6082,UCSD-NCI-6082
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060372
Other Hematopoietic And Lymphoid Cancer Studies:
1. Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer
2. A Pilot Trial of AC (Adriamycin, Cyclophosphamide) Chemotherapy with G-CSF (Granulocyte Colony-Stimulating Factor) Followed by Infusional Taxol (Paclitaxel) as Adjuvant Treatment for High Risk Stage II and Stage III Breast Cancer Patients
3. Polyphenon E (Green Tea Extract) and Low-Dose Aspirin in Preventing Cancer in Women at High Risk For Developing Breast Cancer
4. Peripheral Stem Cell Transplantation Plus Monoclonal Antibody Therapy in Treating Patients With High-Risk Hematologic Cancer, Refractory Breast or Kidney Cancer, or Melanoma
5. Phase I/II Trial of Doxil and Hyperthermia for Breast Cancer Patients with Chest Wall Recurrence or Stage IV Disease with Locally Advanced Breast Cancer
Related Studies:
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Monoclonal Antibody Therapy After Allogeneic Stem Cell Transplantation in Treating Patients With Persistent or Progressive Cancer
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