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Sponsors and Collaborators: |
Baylor College of Medicine Pediatric Brain Tumor Consortium |
Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00586560 |
This is a Phase 1, open-label, single-center, dose-escalating study in pediatric patients with refractory or recurrent solid tumors. Patients will be registered into 1 of 2 strata, depending upon the presence bone marrow metastases or previous treatment with intensive myelosuppression therapy. Patients will receive Karenitecin along with cyclophosphamide daily for 5 consecutive days, every 21 days (1 treatment cycle). Treatment may continue for up to 20 cycles, as long as there is continued evidence of clinical benefit and an absence of unacceptable toxicity.
Condition | Intervention | Phase |
Solid Tumors |
Drug: Kareniticin and cyclophosphamide |
Phase I |
MedlinePlus related topics: | Cancer |
ChemIDplus related topics: | Cyclophosphamide Granulocyte colony-stimulating factor Karenitecin |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety Study |
Official Title: | A Phase 1 Trial of Escalating Doses of Karenitecin Plus Cyclophosphamide Administered Intravenously Daily for 5 Consecutive Days in Pediatric Patients With Refractory or Recurrent Solid Tumors |
Estimated Enrollment: | 50 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Stratum 1 (~ 25 patients) will include patients with known bone marrow metastases or those who have had prior intensive myelosuppression therapy (including autologous or allogeneic stem cell rescue [SCR], total body irradiation [TBI], craniospinal irradiation [CSI], or hemipelvic radiation).
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Drug: Kareniticin and cyclophosphamide
An accelerated titration dose escalation design will be used in this study. Dose escalation will function independently for each stratum. Patients in both strata will receive Karenitecin and cyclophosphamide administered as an IV infusion each day for 5 consecutive days. In addition, patients in Stratum 1 will receive prophylactic G-CSF starting 24 hours after completion of the fifth dose of Karenitecin and cyclophosphamide (and continuing daily until the ANC is over 1500/mm3 after nadir). The regimen will be repeated every 21 days (1 treatment cycle). Treatment may continue for up to 20 cycles, provided there is continued evidence of clinical benefit and absence of unacceptable toxicity. |
2: Experimental
Stratum 2 (~ 25 patients) will include patients without previous intensive myelosuppressive therapy and bone marrow metastases.
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Drug: Kareniticin and cyclophosphamide
An accelerated titration dose escalation design will be used in this study. Dose escalation will function independently for each stratum. Patients in both strata will receive Karenitecin and cyclophosphamide administered as an IV infusion each day for 5 consecutive days. In addition, patients in Stratum 1 will receive prophylactic G-CSF starting 24 hours after completion of the fifth dose of Karenitecin and cyclophosphamide (and continuing daily until the ANC is over 1500/mm3 after nadir). The regimen will be repeated every 21 days (1 treatment cycle). Treatment may continue for up to 20 cycles, provided there is continued evidence of clinical benefit and absence of unacceptable toxicity. |
This is a Phase 1, open-label, dose-escalating study of karenitecin plus cyclophosphamide in the treatment of pediatric patients with refractory or recurrent solid tumors. All patients must have histologically documented diagnosis of cancer (solid tumors) refractory to conventional therapeutic modalities or for which no curative treatment exists.
Approximately 50 patients will be registered into the study in one of 2 strata.
Stratum 1 will include patients with known bone marrow metastases or those who have had prior intensive myelosuppression therapy. Stratum 2 will include patients without previous intensive myelosuppressive therapy or bone marrow metastases. Each stratum will accrue patients independently.
The primary endpoint in this study is the MTD and determining the recommended Phase 2 dose level for this study. The MTD will be determined for each stratum independently.
There are 3 defined periods in this study:
Period I (Screening and Registration)
Period II (Active Treatment): An accelerated titration dose escalation design will be used in this study. Dose escalation will function independently for each stratum.
Period III (End of Study): Once treatment has been discontinued, patients will undergo end-of-study procedures.
Ages Eligible for Study: | 12 Months to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Karnofsky score greater than or equal to 60 (patients over 10 years of age) and Lansky score greater than or equal to 60 (patients 10 years of age or less). Performance status scales/scores are provided in Appendix E in full protocol attached in Section S.
Note: Neurological deficits in patients with CNS tumors must have been stable for a minimum of one week before study entry. Patients who are unable to walk because of paralysis, but who are up in a wheelchair will be considered ambulatory for performance score assessment.
Adequate renal function; defined as: •Creatinine clearance or radioisotope glomerular filtration rate (GFR) 70 mL/min/m2 or greater.
OR
• Serum creatinine based on age as follows: 5 years or less - 0.8 or less mg/dL over 5 years to 10 years old - 1.0 or less mg/dL over 10 years to 15 years old - 1.2 or less mg/dL over 15 years old - 1.5 or less mg/dL
Exclusion Criteria:
Contact: Susan Blaney, MD | 832-822-4586 | smblaney@txccc.edu |
United States, Texas | |||||
Texas Children's Hospital | Recruiting | ||||
Houston, Texas, United States, 77030 | |||||
Principal Investigator: Susan Blaney, MD |
Baylor College of Medicine |
Pediatric Brain Tumor Consortium |
Principal Investigator: | Susan Blaney, MD | Baylor College of Medicine |
Responsible Party: | Baylor College of Medicine ( Susan Blaney ) |
Study ID Numbers: | H-20159, KTN10010, BMP1350 |
First Received: | December 20, 2007 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00586560 |
Health Authority: | United States: Food and Drug Administration |
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