Phase II study of weekly Vinorelbine and Topotecan administration treatment for refractory adult rhabdomyosarcoma previously treated by VAC regimen

Phase II study of weekly Vinorelbine and Topotecan administration treatment for refractory adult rhabdomyosarcoma previously treated by VAC regimen - V-TOP trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008202

Enrollment

Registered

2012-06-20

Start date

2011-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult rhabdomyosarcoma with prior VAC therapy

Interventions

Vinorelvine 20 mg/m-2 day 1, 8 Topotecan 4 mg/m-2 day 1, 8 q 3 weeks until disease progression or intorelable toxicities

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: a) age >= 20 years old b) PS 0 to 2 c) no annormal findings on ECG d) no massive ascitis and ileus e) appropriate organ finctions (1) WBC 3,000/mm-3 <= or ANC <= 1,000/mm-3, Platlet >= 100,000/mm-3 (2) AST and ALT < 5 times x upper normal limit (3) Total birilubin < 1.5 mg/dL (4) serum creatinine < 1.5 mg/dL f) no prior treatment wih vinorelbine, topotecan and irinotecan g) more than one weeks after the completion of prior treatment (radiotherapy, surgery, or chemotherapy) h) written informed consent

Exclusion criteria

Exclusion criteria: a) pregancy b) sereve infection c) interstitual pneumonia or lung fibrosis d) symptomatic CNS metastases e) HIV infection f) nuerotoxicity with >= grade 3

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
Progression-free survival Overall survival Adverse events	—

Countries

Japan

Contacts

Public ContactMakoto Kodaira

National Cancer Center Hospital Division of breast and medical oncology

03-3542-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026