Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477906
Status:
UNKNOWN
Last Update Posted:
2015-12-03
First Post:
2007-05-22
Brief Title:
M-Vax Low Dose Interleukin-2 Versus Placebo Vaccine in Metastatic Melanoma in Patients With Stage IV Melanoma
Sponsor:
AVAX Technologies
Organization:
AVAX Technologies
Study Overview
Official Title:
Comparison of M-Vax Plus Low Dose Interleukin-2 Versus Placebo Vaccine Plus Low Dose Interleukin-2 in Patients With Stage IV Melanoma
Status:
UNKNOWN
Status Verified Date:
2015-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Previous studies suggests that M-Vax a melanoma vaccine prepared from patients own cancer cells can stimulated patients immune system to react against their cancer AVAX has identified a dose and schedule of administration of M-Vax that work optimally In this study AVAX will determine whether M-Vax is effective in shrinkage of melanomas that have spread stage IV To increase it effectiveness M-Vax administration will be followed by administration of low doses of interleukin-2 IL2 a marketed drug that is known to stimulate immunity and cause some shrinkage of melanomas Two-thirds of patients will receive M-Vax IL2 and one-third will receive a placebo vaccine IL2 The study is blinded so that neither the patients nor their physicians know which material they are receiving
To be eligible for this study patients must have at least one melanoma tumor that can be surgically removed and made into a vaccine In addition they must have melanoma that has spread to to the lungs or to soft tissue sites under the skin on the surface of the skin lymph nodes Eligible patients may have previously received one treatment for example chemotherapy for their melanoma
Side effects of M-Vax are expected to be mild the most common is the development of sore pimples at the site of vaccine injections The low dose IL2 may cause some fatigue and other mild symptoms
It is expected that 387 patients will be treated in this study
To be eligible for this study patients must have at least one melanoma tumor that can be surgically removed and made into a vaccine In addition they must have melanoma that has spread to to the lungs or to soft tissue sites under the skin on the surface of the skin lymph nodes Eligible patients may have previously received one treatment for example chemotherapy for their melanoma
Side effects of M-Vax are expected to be mild the most common is the development of sore pimples at the site of vaccine injections The low dose IL2 may cause some fatigue and other mild symptoms
It is expected that 387 patients will be treated in this study
Detailed Description:
M-Vax is a therapeutic melanoma vaccine consisting of autologous melanoma cells that have been irradiated and then modified with the hapten dinitrophenyl DNP There is a large amount of published evidence that hapten modification makes visible to the immune system antigens including tumor antigens that otherwise do not elicit an immune response
This is a Phase III randomized placebo-controlled double-blind multi-centered trial of M-Vax in patients with stage IV melanoma with measurable metastases in lung andor soft tissues To be eligible for screening patients will have undergone surgery for therapeutic intervention which yields an adequate amount of melanoma tumor cells for preparation of vaccines which pass vaccine release testing Eligible patients who meet all inclusionexclusion criteria will be enrolled in the study
Patients will be assigned in a double-blind fashion to M-Vax or Placebo Vaccine at a 21 ratio M-VaxPlacebo Vaccine The dose of M-Vax will be 40-200x106 DNP-modified autologous melanoma tumor cells The Placebo Vaccine will consist of diluent only An initial dose of M Vax or Placebo Vaccine will be administered without BCG followed by low dose cyclophosphamide 300 mgm2 iv Then M Vax or Placebo Vaccine mixed with Bacillus of Calmette and Guérin BCG will be administered weekly for 6 weeks Four courses of interleukin-2 IL2 will be administered to all patients starting about 2 weeks after the last vaccine each course will consist of 3 million unitsm2 subcutaneously daily for 5 days followed by a 16-day rest period
The primary endpoints of the study are 1Best overall anti-tumor response and 2Survival measured by surviving at two years Patients will be evaluated for anti-tumor response by modified RECIST criteria between weeks 24 and 25 ie 5-6 weeks after completion of IL2 At the 6-month point patients who remain on study will receive an additional single booster dose of M-Vax or Placebo Vaccine mixed with BCG This will be followed by four more courses of IL2 Two additional evaluations for anti-tumor response will take place at the 38-39 week month 9 and one-year points Then patients will be regularly evaluated for tumor status and adverse events until evidence of tumor progression that requires new therapy Patients who remain on-study will be followed until death but for a maximum of 5 years
The intended sample size is 387 and there will be about 25 sites participating in the United States Europe and Israel An interim analysis will be performed after half the patients have been accrued
This is a Phase III randomized placebo-controlled double-blind multi-centered trial of M-Vax in patients with stage IV melanoma with measurable metastases in lung andor soft tissues To be eligible for screening patients will have undergone surgery for therapeutic intervention which yields an adequate amount of melanoma tumor cells for preparation of vaccines which pass vaccine release testing Eligible patients who meet all inclusionexclusion criteria will be enrolled in the study
Patients will be assigned in a double-blind fashion to M-Vax or Placebo Vaccine at a 21 ratio M-VaxPlacebo Vaccine The dose of M-Vax will be 40-200x106 DNP-modified autologous melanoma tumor cells The Placebo Vaccine will consist of diluent only An initial dose of M Vax or Placebo Vaccine will be administered without BCG followed by low dose cyclophosphamide 300 mgm2 iv Then M Vax or Placebo Vaccine mixed with Bacillus of Calmette and Guérin BCG will be administered weekly for 6 weeks Four courses of interleukin-2 IL2 will be administered to all patients starting about 2 weeks after the last vaccine each course will consist of 3 million unitsm2 subcutaneously daily for 5 days followed by a 16-day rest period
The primary endpoints of the study are 1Best overall anti-tumor response and 2Survival measured by surviving at two years Patients will be evaluated for anti-tumor response by modified RECIST criteria between weeks 24 and 25 ie 5-6 weeks after completion of IL2 At the 6-month point patients who remain on study will receive an additional single booster dose of M-Vax or Placebo Vaccine mixed with BCG This will be followed by four more courses of IL2 Two additional evaluations for anti-tumor response will take place at the 38-39 week month 9 and one-year points Then patients will be regularly evaluated for tumor status and adverse events until evidence of tumor progression that requires new therapy Patients who remain on-study will be followed until death but for a maximum of 5 years
The intended sample size is 387 and there will be about 25 sites participating in the United States Europe and Israel An interim analysis will be performed after half the patients have been accrued
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None