Topotecan, Ifosfamide and Carboplatin in Children and Young Adults With Solid Tumors
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00502892
First received: July 16, 2007
Last updated: July 31, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumors |
Drug: Topotecan Drug: Ifosfamide Drug: Carboplatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of a Novel Chemotherapeutic Regimen: Topotecan, Ifosfamide and Carboplatin (TIC) in Children and Young Adults With Solid Tumors-- A Limited Multi-Institution Study |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Maximum tolerated dose (MTD) [ Time Frame: Blood tests on Days 1, 3, 5, then twice weekly and on Day 22 of each course; Urine tests done on Day 1 of each course and at end of Course 2. ] [ Designated as safety issue: Yes ]
| Enrollment: | 2 |
| Study Start Date: | August 2004 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Topotecan + Ifosfamide + Carboplatin |
Drug: Topotecan
0.5 mg/m^2 IV Daily x 3 Days
Other Name: Hycamtin
Drug: Ifosfamide
1.8 grams/m^2 IV Over 1 Hour x 5 Days
Other Name: Ifex
Drug: Carboplatin
AUC = 3 mg/ml/min IV Over 1 Hour x 3 Days [for patients > 22 yrs of age, 3 mg/mL/min IV Over 1 Hour x 2 Days]
Other Name: Paraplatin
|
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age </= 45years.
- 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)
- 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.
- Performance Level: Karnofsky >/= 70% for patients >10 years of age and Lansky Play-Performance Scale >/=70 for children </= 10 years of age. Neurologic deficits in 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.
- Life Expectancy >/= 8 weeks.
- Full recovery from acute toxic effects of all prior chemo, immuno or XRT: a. No myelosuppressive chemotherapy </=2 weeks (4 weeks if prior nitrosourea). b. At least 7 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.
- Adequate Bone Marrow Function: ANC >/=1000/ micro L; Platelets >/= 50,000/ micro L (transfusion independent); Hgb >/= 8.0 gm/dL (may receive RBC transfusions).
- Adequate Renal function: Serum creatinine </= 1.5 x normal for age, or Creatinine clearance or radioisotope GFR >/= lower limit of normal for age.
- Adequate Liver function: Total bilirubin </=1.5 x normal for age, and SGPT (ALT) </= 5 x normal for age and albumin >/=2 g/dL.
- Adequate Cardiac Function: Shortening fraction of >/= 27% by echocardiogram, or Ejection fraction of >/= 50% by gated radionuclide study.
- Adequate Pulmonary Function: No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% if there is clinical indication for determination.
- Central Nervous System Function: Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled. CNS toxicity < Grade 2.
- Signed Informed Consent.
Exclusion Criteria:
- Pregnancy or Breast Feeding.
- Prior therapy with this particular topotecan, ifosfamide, carboplatin regimen in last 3 months.
- Patients with bone marrow solid tumor involvement.
- 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.
- Patients with evidence of active graft vs. host disease and/or patients wiht allogeneic Stem Cell Transplant [SCT], < 6 months.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502892
Locations
| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Robert J. Wells, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00502892 History of Changes |
| Other Study ID Numbers: | 2004-0079 |
| Study First Received: | July 16, 2007 |
| Last Updated: | July 31, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Solid Tumors Topotecan Hycamtin Ifosfamide Ifex |
Carboplatin Paraplatin Pediatric Children Young Adults |
Additional relevant MeSH terms:
|
Neoplasms Ifosfamide Isophosphamide mustard Carboplatin Topotecan Antineoplastic Agents, Alkylating Alkylating Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013