MDACC Study Summary 2004-0079 (Archived)

Study Summary
No. 2004-0079:.......Bone; Brain; CNS; Eye; Kidney; Liver; Lymphoma; Melanoma; Neural; Pediatrics; Sarcoma; Testis......Robert J. Wells......Pediatrics

Study Summary Title



Study Summary Number:	2004-0079

Study 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

Physician

New Patient Referral



Name:	Robert J. Wells	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Pediatrics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-1499 Contact us about clinical trials

General Information



Disease Group:	Bone Brain CNS Eye Kidney Liver Lymphoma Melanoma Neural Pediatrics Sarcoma Testis	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	Weekly outpatient visits {not necessarily at MDACC} for toxicity monitoring

Treatment Agents:	Cyclophosphamide Filgrastim GM-CSF Ifosfamide Topotecan	Home Care:	NONE

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	5-6 day hospitalization every three + weeks


Description/ Intervention:	The goal of this clinical research study is find the highest safe dose of topotecan that can be given with carboplatin and ifosfamide in the treatment of recurrent/refractory solid tumors. The safety of this combination treatment and how well the disease responds to this treatment will also be studied.

Study Objectives / Outcomes

HYPOTHESIS

1.1
Repetitive courses of the combination of Topotecan, Ifosfamide and Carboplatin (TIC) will be a novel and efficacious chemotherapeutic regimen for children and young adults with solid tumors.

PRIMARY AIMS

1.2
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.

1.3
To evaluate the toxicity associated with the administration of Topotecan with Ifosfamide and Carboplatin (TIC) in children and young adults with solid tumors.

SECONDARY AIMS

1.4
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.

1.5
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.(Elective)

1.6
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. (Elective)

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	07/21/2004

Study Type:

Recruitment Status:	Terminated

Projected Accrual:	78

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Age < / = 45years.

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 </= 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.

5) Life Expectancy >/= 8 weeks.

6) 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.

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 </= 1.5 x normal for age, or Creatinine clearance or radioisotope GFR >/= lower limit of normal for age.

9) Adequate Liver function: Total bilirubin </=1.5 x normal for age, and SGPT (ALT) </= 5 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.

Links

Registration Number: NCT00502892
Study Information on Clinical Trials Registry (clinicaltrials.gov)