Overview

Topotecan, Ifosfamide and Carboplatin in Children and Young Adults With Solid Tumors

Status:
Completed
Trial end date:
2010-01-01
Target enrollment:
0
Participant gender:
All
Summary
Primary Objectives: - To determine the maximum tolerated dose (MTD) of Topotecan when added to a fixed dose regimen of Ifosfamide and Carboplatin in children and young adults with solid tumors. - To evaluate the toxicity associated with the administration of Topotecan with Ifosfamide and Carboplatin (TIC) in children and young adults with solid tumors. Secondary Objectives: - To evaluate the duration of neutropenia (ANC<500/micro L) and thrombocytopenia (PLT 50,000/ micro L and 20,000/ micro L) and the number of days of platelet transfusion during each course of TIC chemotherapy when used in conjunction with G-CSF and NEUMEGA in children and young adults with solid tumors. - To determine the median number of apheresis collections as well as the CD34/kg, CD41/kg, CD61/kg and CD34:41/kg and CD34:61/kg per collection in patients electively undergoing concurrent apheresis for peripheral blood stem cell collection in courses 2 or 3. - To determine the median number of peripheral blood mononuclear cells (PBMC) and ex-vivo expanded myeloid dendritic cells (DC) in patients electively undergoing concurrent apheresis for PBMC collection in courses 2 or 3.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Carboplatin
Ifosfamide
Isophosphamide mustard
Topotecan
Criteria
Inclusion Criteria:

1. Age
2. Histologic proof of solid tumor malignancy (excluding brain stem tumors) at initial
diagnosis. Diagnostic Categories include: a) Sarcoma (Soft Tissue and Bone), b) Kidney
Tumors, c) Brain Tumors, d) Neuroblastoma, e) Hodgkin's disease and non-Hodgkin's
lymphoma, f) Other solid tumors (gonadal and germ cell tumors, malignant melanoma,
retinoblastoma, liver tumors, and miscellaneous tumors)

3. If previously treated, must have radiographic, nuclear image, or biopsy proof that
they have had a recurrence of their disease within 4 weeks prior to study entry.

4. Performance Level: Karnofsky >/= 70% for patients >10 years of age and Lansky
Play-Performance Scale >/=70 for children patients with CNS tumors must have been relatively stable for a minimum of 2 weeks
prior to study entry. Patients who are unable to walk because of paralysis, but who
are up in a wheelchair will be considered ambulatory for the purpose of assessing the
performance score.

5. Life Expectancy >/= 8 weeks.

6. Full recovery from acute toxic effects of all prior chemo, immuno or XRT: a. No
myelosuppressive chemotherapy days since completion of therapy with biologic agent (anti-neoplastic agent). c. No
cranial-spinal &/or spinal (>3600 cGy) XRT. No XRT (including TBI) to > 50% of bone
marrow space. d. No evidence of active GVHD. For allogeneic Stem Cell Transplant
(SCT), >/= 6 months must have elapsed. e. Has NOT received exact combination & dosage
of Topotecan, Carboplatin, & Ifosfamide, as this study recommends, within last 3
months.

7. Adequate Bone Marrow Function: ANC >/=1000/ micro L; Platelets >/= 50,000/ micro L
(transfusion independent); Hgb >/= 8.0 gm/dL (may receive RBC transfusions).

8. Adequate Renal function: Serum creatinine clearance or radioisotope GFR >/= lower limit of normal for age.

9. Adequate Liver function: Total bilirubin x normal for age and albumin >/=2 g/dL.

10. Adequate Cardiac Function: Shortening fraction of >/= 27% by echocardiogram, or
Ejection fraction of >/= 50% by gated radionuclide study.

11. Adequate Pulmonary Function: No evidence of dyspnea at rest, no exercise intolerance,
and a pulse oximetry > 94% if there is clinical indication for determination.

12. Central Nervous System Function: Patients with seizure disorder may be enrolled if on
anticonvulsants and well controlled. CNS toxicity < Grade 2.

13. Signed Informed Consent.

Exclusion Criteria:

1. Pregnancy or Breast Feeding.

2. Prior therapy with this particular topotecan, ifosfamide, carboplatin regimen in last
3 months.

3. Patients with bone marrow solid tumor involvement.

4. Patients having received cranial-spinal and or spinal irradiation (>3600 cGy).
Patients who have received radiation therapy (including TBI) to greater than 50% of
the bone marrow space.

5. Patients with evidence of active graft vs. host disease and/or patients wiht
allogeneic Stem Cell Transplant [SCT], < 6 months.