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Portland, Oregon 97239

  • Lymphoma

Purpose:

RATIONALE: LMB-2 immunotoxin can locate cancer cells and kill them without harming normal cells. PURPOSE: This phase I trial is studying the side effects and best dose of LMB-2 immunotoxin in treating young patients with relapsed or refractory leukemia or lymphoma.


Study summary:

OBJECTIVES: Primary - Determine the maximum tolerated dose of LMB-2 immunotoxin in pediatric patients with CD-25 positive relapsed or refractory leukemia or lymphoma. - Determine the toxic effects of this drug in these patients. - Determine the pharmacokinetics of this drug, including the terminal elimination serum half-life, area under the curve, volume of distribution, and relationship to disease burden, in these patients. Secondary - Evaluate the immonogenicity of this drug in these patients. - Determine response in patients treated with this drug. - Determine changes in lymphocyte subsets, immunoglobulin levels, serum cytokines, and soluble cytokine receptor levels in patients treated with this drug. OUTLINE: This is a dose-escalation, multicenter study. Patients receive LMB-2 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression, neutralizing antibodies (i.e., > 75% of the activity of 1 µg/mL of LMB-2 immunotoxin), or unacceptable toxicity. Patients achieving complete remission (CR) receive 2 additional courses beyond CR. Patients with acute lymphoblastic leukemia also receive cytarabine and hydrocortisone intrathecally once monthly concurrent with restaging lumbar punctures. Cohorts of 3-6 patients receive escalating doses of LMB-2 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, a total of 12 patients are treated at that dose level. Patients are followed weekly for 1 month and then monthly thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 2-4 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed diagnosis of 1 of the following: - Non-Hodgkin's lymphoma, including the following subtypes: - Lymphoblastic lymphoma - Burkitt's lymphoma - Large cell lymphoma - Adult T-cell leukemia/lymphoma - Cutaneous T-cell lymphoma - Peripheral T-cell lymphoma - Hodgkin's disease - Acute myeloid leukemia - Chronic myelogenous leukemia - Acute lymphoblastic leukemia (ALL) - More than 5% blasts in the bone marrow (i.e., M2 marrow classification) - Acute hybrid leukemia, including the following subtypes: - Mixed lineage leukemia - Biphenotypic leukemia - Undifferentiated leukemia - CD25-positive (CD25+) disease, meeting 1 of the following criteria: - More than 15% of malignant cells are CD25+ by immunohistochemistry with anti-CD25 antibody - More than 30% of malignant cells from a site are CD25+ by fluorescence-activated cell sorting analysis - Measurable or evaluable disease - Relapsed or refractory disease after at least 1 standard chemotherapy regimen AND 1 salvage regimen - No available alternative curative therapies - Ineligible for or refused hematopoietic stem cell transplantation OR disease activity that prohibits the required time to identify a suitable stem cell donor - No CNS leukemia or lymphoma, as evidenced by any of the following criteria: - Cerebrospinal fluid (CSF) WBC > 5/µl AND confirmation of CSF blasts - Cranial neuropathies secondary to underlying malignancy - CNS lymphoma detected by radiological imaging - Prior CNS involvement with no current evidence of CNS malignancy allowed - No isolated testicular ALL PATIENT CHARACTERISTICS: Age - 6 months to 21 years Performance status - ECOG 0-3 (≥ 12 years of age) - Lansky 40-100% (< 12 years of age) Life expectancy - Not specified Hematopoietic - Pancytopenia due to disease allowed - For patients without bone marrow involvement: - Absolute neutrophil count > 1,000/mm^3 - Platelet count > 50,000/mm^3 (transfusion independent) Hepatic - Bilirubin ≤ 2.0 mg/dL - AST and ALT ≤ 5 times upper limit of normal - Hepatitis B surface antigen negative - Hepatitis C antibody negative Renal - Creatinine clearance ≥ 60 mL/min OR - Creatinine, meeting the following age-related criteria: - ≤ 0.8 mg/dL (≤ 5 years of age) - ≤ 1.0 mg/dL (6 to 10 years of age) - ≤ 1.2 mg/dL (11 to 15 years of age) - ≤ 1.5 mg/dL (> 15 years of age) - Calcium 2.0-2.9 mmol/L Cardiovascular - Ejection fraction ≥ 45% by MUGA OR - Shortening fraction ≥ 28% by echocardiogram Pulmonary - Oxygen saturation ≥ 90% Other - Sodium 130-150 mmol/L - Potassium 3.0-5.5 mmol/L - Magnesium 0.5-1.23 mmol/L - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No clinically significant unrelated systemic illness that would preclude study participation - No conditions that would preclude study compliance - No serum that neutralizes > 75% of the activity of 1 μg/mL of LMB-2 immunotoxin in tissue culture (due to either anti-toxin or anti-mouse immunoglobulin G antibodies) - No active graft-vs-host disease (i.e., off immunosuppression) PRIOR CONCURRENT THERAPY: Biologic therapy - Prior autologous bone marrow transplantation (BMT) allowed - At least 100 days since prior allogeneic BMT - At least 1 week since prior colony-stimulating factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], or epoetin alfa) Chemotherapy - At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) except intrathecal chemotherapy - No other concurrent chemotherapy Endocrine therapy - Concurrent corticosteroids allowed provided the dose has been stable for the past week and does not increase during study treatment - Tapering or discontinuation of steroids allowed Radiotherapy - At least 3 weeks since prior radiotherapy unless < 10% of marrow is irradiated and measurable disease exists outside the radiation port Surgery - Not specified Other - Recovered from all prior therapy - At least 30 days since prior investigational agents - Concurrent oral supplementation to maintain normal electrolyte levels allowed - No concurrent anticoagulation therapy for disease-related conditions - No other concurrent investigational agents


Study is Available At:


Original ID:

CDR0000367333


NCT ID:

NCT00085150


Secondary ID:

NCI-04-C-0168


Study Acronym:


Brief Title:

LMB-2 Immunotoxin in Treating Young Patients With Relapsed or Refractory Leukemia or Lymphoma


Official Title:

Pediatric Phase I Trial of LMB-2 for Refractory CD25-Positive Leukemias and Lymphomas


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

N/A


Maximum Age:

21 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Alan S. Wayne, MD
Principal Investigator
National Cancer Institute (NCI)

Study Dates

Start Date:April 2004
Verification Date:February 2007
Last Changed Date:April 29, 2015
First Received Date:June 10, 2004

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:LMB-2 immunotoxin

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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