A phase I study of vinorelbine, cyclophosphamide and Rapamycin for recurrent malignancies in childre

Phase 1

Completed

• Conditions: recurrent malignancies; Cancer - Children's - Other; Cancer - Children's - Brain

• Registration Number: ACTRN12613000423718
• Lead Sponsor: Australian New Zealand Childrens Haematology Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-16
• Study Completion: 2021-04-14
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Patients must be < 22 years of age at the time of study entry.
2. Patients must have had histologic verification of the solid tumour/malignancy either at the time of original diagnosis or at relapse (excluding brain stem and optic pathway tumours). Participants are not required to have measurable disease at the time of study entry. The following histologies are eligible: All brain tumours, Rhabdomyosarcoma, Soft tissue sarcomas, Osteogenic sarcoma, Ewing sarcoma, Neuroblastoma, Wilms’ tumour.
3. Patient’s disease must be relapsed or refractory following initial therapy.
4. Patient’s disease must be one for which there is no curative therapy.
5. Performance: Karnofsky greater than or equal 50% for patients 16 years of age and over and Lansky greater than or equal 50 for patients less than 16 years of age. 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.
6. Life expectancy must be greater than or equal 8 weeks
7. Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea). Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent. XRT: greater than or equal 2 wks for local palliative XRT (small port); greater than or equal 6 months must have elapsed if prior craniospinal XRT or if greater than or equal 50% of the pelvis has been radiated; greater than or equal 6 wks must have elapsed if other substantial BM radiation. Patients with recurrent brain tumours should be greater than or equal 8 weeks from completion of standard fraction radiation unless there is biopsy proof of the presence of recurrent tumour. Patients who underwent radiosurgery within 9 months must have documentation of progressive disease either by biopsy, PET scan or MR spectroscopy.
8. Concomitant medications: Growth factor(s) must not have received within 1 week of entry onto this study. Systemic corticosteroid therapy is permissible only in patients with CNS tumours for treatment of increased intracranial pressure or symptomatic tumour oedema. Patients with CNS tumours who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to study entry.
9. Organ Function Requirements: Adequate Bone Marrow Function Defined as: Peripheral absolute neutrophil count (ANC) > 1000/microL, Platelet count > 100,000/microL (transfusion independent, i.e. patients must not have received platelet transfusions within 7 days of enrolment), Haemoglobin > 80.0 g/L (may receive RBC transfusions). Adequate Renal Function Defined As: Creatinine clearance or radioisotope GFR greater than or equal 70ml/min/1.73 m2 and a normal serum creatinine based on age. Adequate Liver Function Defined As: Total bilirubin < 1.5 x upper limit of normal (ULN) for age, and ALT < 2.5 x upper limit of normal (ULN) for age and albumin greater than or equal 20 g/L.
10. All patients and/or their parents or legal guardians must sign a written informed consent. All institutional ethics requirements for human studies must be met prior to patient accrual.

Exclusion Criteria

1. Pregnant or lactating females are ineligible as the medications used in this protocol could be harmful to unborn children and infants. Pregnancy tests must be obtained in girls who are post-menarche. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
2. Patients who have an uncontrolled infection are excluded from this study.
3. Patients who have previously received Rapamycin, Everolimus, Tacrolimus or Temsirolimus are excluded from this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified