Metronomic Therapy in Patients With Metastatic Melanoma
This study is ongoing, but not recruiting participants.
Sponsor:
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Marc S. Ernstoff, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01542255
First received: January 17, 2012
Last updated: January 29, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Melanoma |
Drug: vinblastine Drug: Cyclophosphamide Drug: dacarbazine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Metronomic Therapy in Patients With Metastatic Melanoma: A Phase II Study of Low Dose Vinblastine, Cyclophosphamide, and Dacarbazine |
Resource links provided by NLM:
Further study details as provided by Dartmouth-Hitchcock Medical Center:
Primary Outcome Measures:
- Progression Free Survival [ Time Frame: 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 ] [ Designated as safety issue: No ]Tumor evaluation will be performed every 8 weeks from day 1 of cycle 1 (+/- 1 week) while on therapy.
Secondary Outcome Measures:
- Clinical response rate [ Time Frame: 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. ] [ Designated as safety issue: No ]To be assigned a status of partial response or complete response, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. In the case of stable disease, follow-up measurements must have met the stable disease criteria at least once after study entry at a minimum interval (in general, not less than 6-8 weeks) that is defined in the study protocol
| Estimated Enrollment: | 29 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Combined Low Dose Treatment
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
1 mg/m2 vinblastine given three times per week administered intravenously.
Other Name: Velban
Drug: Cyclophosphamide
60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest
Other Name: Cytoxan
Drug: dacarbazine
15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest
Other Name: DTIC
|
Detailed Description:
Low dose continuous chemotherapy, called metronomic chemotherapy, is designed to target vascular cells and inhibit tumor growth and metastasises. A recent study in a melanoma mouse model has identified low dose vinblastine, cyclophosphamide and dacarbazine as a treatment which improves the animal's survival and is superior to full dose dacarbazine alone. This clinical trial seeks to translate this laboratory model directly into metastatic melanoma patients.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
- Metastatic melanoma with measurable disease
- Patients must be at least 4 weeks from their last immunotherapy, radiation, surgery or chemotherapy (6 weeks for nitrosoureas) and recovered from all ill
- Karnofsky Performance Status ≥60%
- Life expectancy ≥ twelve weeks
- Adequate end organ function
- Women should not be lactating and, if of childbearing age, have a negative pregnancy test within two weeks of entry to the study.
- Appropriate Contraception in both sexes
- The patient must be competent and signed informed consent.
EXCLUSION CRITERIA
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542255
Locations
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
| Principal Investigator: | Marc S. Ernstoff, MD | Dartmouth-Hitchcock Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Marc S. Ernstoff, Associate Director for Clinical Research, Dartmouth-Hitchcock Medical Center |
| ClinicalTrials.gov Identifier: | NCT01542255 History of Changes |
| Other Study ID Numbers: | D1010, 22362 |
| Study First Received: | January 17, 2012 |
| Last Updated: | January 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dartmouth-Hitchcock Medical Center:
|
Metronomic Therapy Metastatic Melanoma Vinblastine Cyclophosphamide Dacarbazine |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Cyclophosphamide Dacarbazine Vinblastine Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |
ClinicalTrials.gov processed this record on June 18, 2013