NCT00502892

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

5.4 years

First QC Date

July 16, 2007

Last Update Submit

July 31, 2012

Conditions

Solid Tumors

Keywords

Solid TumorsTopotecanHycamtinIfosfamideIfexCarboplatinParaplatinPediatricChildrenYoung Adults

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose (MTD)

    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.

Study Arms (1)

Topotecan + Ifosfamide + Carboplatin

EXPERIMENTAL
Drug: TopotecanDrug: IfosfamideDrug: Carboplatin

Interventions

TopotecanDRUG

0.5 mg/m\^2 IV Daily x 3 Days

Also known as: Hycamtin
Topotecan + Ifosfamide + Carboplatin
IfosfamideDRUG

1.8 grams/m\^2 IV Over 1 Hour x 5 Days

Also known as: Ifex
Topotecan + Ifosfamide + Carboplatin
CarboplatinDRUG

AUC = 3 mg/ml/min IV Over 1 Hour x 3 Days \[for patients \> 22 yrs of age, 3 mg/mL/min IV Over 1 Hour x 2 Days\]

Also known as: Paraplatin
Topotecan + Ifosfamide + Carboplatin

Eligibility Criteria

AgeUp to 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

TopotecanIfosfamideCarboplatin

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingCoordination Complexes

Study Officials

  • Robert J. Wells, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 18, 2007

Study Start

August 1, 2004

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

US(1)