Metronomic Therapy in Patients With Metastatic Melanoma

NCT01542255 | Terminated Phase 2 Results DMC

• 2 other identifiers: D101022362
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

SUMMARY: Metronomic Therapy in Patients with Metastatic Melanoma: A Phase II Study of Low Dose Vinblastine, Cyclophosphamide, and Dacarbazine. Patients with measurable metastatic melanoma are eligible. All patients will be treated as outlined below with combined vinblastine, cyclophosphamide, and dacarbazine. Patients will be treated continuously, until evidence of progression of disease, or for up to two cycles following disappearance of all disease. A cycle will be defined as three weeks of continuous therapy with a one week rest.

Conditions

Metastatic Melanoma

Keywords

Metronomic Therapy; Metastatic Melanoma; Vinblastine; Cyclophosphamide; Dacarbazine

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Tumor evaluation will be performed every 8 weeks from day 1 of cycle 1 (+/- 1 week) while on therapy assessed by RECIST 1.0 criteria.

  From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Secondary Outcomes (1)

• Clinical Response Rate

  Tumor evaluation will be performed every 8 weeks from day1 of cycle 1 (+ 1 week) while on therapy, clinical response will be assessed no less than 4 weeks after response criteria met.

Study Arms (1)

Combined Low Dose Treatment

EXPERIMENTAL

A cycle of therapy is 3 weeks of continuous dosing with a 1 week rest. Schema of treatment is: 1 mg/m2 vinblastine three times a week iv 60 mg/m2 cyclophosphamide by mouth 15 mg/m2 dacarbazine three times a week iv

Drug: vinblastine; Drug: Cyclophosphamide; Drug: dacarbazine

Interventions

vinblastine DRUG

1 mg/m2 vinblastine given three times per week administered intravenously.

Also known as: Velban

Combined Low Dose Treatment

Cyclophosphamide DRUG

60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest

Also known as: Cytoxan

Combined Low Dose Treatment

dacarbazine DRUG

15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest

Also known as: DTIC

Combined Low Dose Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Concomitant second malignancy except for non-melanoma skin cancer, and non-invasive cancer such as cervical CIS, superficial bladder cancer without local recurrence, breast CIS.
• In patients with a prior history of invasive malignancy, less than five years in complete remission.
• Have evidence of significant co-morbid illness such as uncontrolled diabetes - Uncontrolled brain metastasis: Patients with brain metastasis most have been treated with brain radiation therapy or surgery and remain clinically stable for a minimum of 4 weeks.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Vinblastine; Cyclophosphamide; Dacarbazine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

terminated early due to difficulty with scheduling three times per week office treatment

Results Point of Contact

• Title: Marc Ernstoff
• Organization: Dartmouth-Hitchcock

marc.s.ernstoff@hitchcock.org

603-650-5534

Study Officials

• Marc S. Ernstoff, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: March 2, 2012
• Study Start: June 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 15, 2019
• Results First Posted: September 9, 2014

Record last verified: 2014-09

Locations

US (1)