Lenalidomide in Treating Young Patients With Relapsed or Refractory Solid Tumors or Myelodysplastic Syndromes

Not Recruiting

Trial ID: NCT00104962


This phase I trial is studying the side effects and best dose of lenalidomide in treating young patients with relapsed or refractory solid tumors or myelodysplastic syndromes. Lenalidomide may stop the growth of solid tumors or myelodysplastic syndromes by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing.

Official Title

Phase I Study of CC-5013 (Lenalidomide NSC# 703813) in Pediatric Patients With Relapsed/Refractory Solid Tumors or Myelodysplastic Syndrome

Stanford Investigator(s)


Inclusion Criteria:

   - Diagnosis of 1 of the following:

      - Histologically confirmed solid tumor

         - No brain tumors

      - Myelodysplastic syndromes (MDS)

         - No refractory anemia with excess blasts in transformation or other forms of
         acute myeloid leukemia (AML)

         - No FAB diagnosis of refractory anemia with excess blasts in transition and
         other forms of AML

         - Newly diagnosed MDS with chromosome 5q abnormalities

   - Relapsed or refractory disease including relapse after stem cell transplantation

   - Measurable or evaluable disease (solid tumor patients only)

   - No known curative or life-prolonging therapy exists

   - No bone marrow involvement by tumor (solid tumor patients only)

   - No CNS tumors

   - Performance status - Karnofsky 50-100% (for patients > 10 years of age)

   - Performance status - Lansky 50-100% (for patients ≤ 10 years of age)

   - Absolute neutrophil count ≥ 1,000/mm^3 (for patients with solid tumors)

   - Platelet count ≥ 100,000/mm^3 (30,000 for patients with MDS)

      - Only patients with MDS may receive transfusions to support platelet counts

   - Hemoglobin ≥ 8.0 g/dL (transfusions allowed)

   - Bilirubin ≤ 1.5 times upper limit of normal (ULN)

   - ALT ≤ 110*

   - Albumin ≥ 2 g/dL

   - Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min

   - Creatinine based on age as follows:

      - Creatinine ≤ 0.8 mg/dL (for patients ≤ 5 years of age)

      - Creatinine ≤ 1 mg/dL (for patients 6 to 10 years of age)

      - Creatinine ≤ 1.2 mg/dL (for patients 11 to 15 years of age)

      - Creatinine ≤ 1.5 mg/dL (for patients over 15 years of age)

   - No parent or sibling with a known history of venous thrombosis before the age of 50 OR
   arterial thrombosis before the age of 40

   - No thromboembolic event except catheter-related thrombosis

   - Not pregnant or nursing

   - Negative pregnancy test

   - Fertile patients must use effective double-method contraception 4 weeks before,
   during, and for ≥ 4 weeks after completion of study treatment

   - Body surface area ≥ 0.4m^2

   - No uncontrolled infection

   - No active graft-vs-host disease from prior stem cell transplant or rescue

   - Recovered from prior immunotherapy

   - At least 1 week since prior biologic agents

   - At least 1 week since prior hematologic growth factors (2 weeks for pegfilgrastim)

   - At least 3 months since prior stem cell transplant or rescue (without total body
   irradiation [TBI])

   - Prior thalidomide allowed

   - No other concurrent immunotherapy

   - No other concurrent biologic therapy

   - More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
   and recovered

   - No concurrent chemotherapy

   - Concurrent dexamethasone allowed provided the dose has been either decreasing or
   stable for the past 7 days

   - See Biologic therapy

   - Recovered from prior radiotherapy

   - At least 2 weeks since prior local palliative (small port) radiotherapy

   - At least 6 months since prior TBI, craniospinal radiotherapy, or radiotherapy to ≥ 50%
   of the pelvis

   - At least 6 weeks since other prior substantial bone marrow radiotherapy

   - No concurrent radiotherapy

   - No other concurrent investigational drugs or agents

   - No other concurrent anticancer agents


drug: lenalidomide

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
LPCH New Patient Coordinator

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