The objective of the trial is to compare the efficacy and safety of treatment with Allovectin 7® versus treatment with DTIC or TMZ in subjects with recurrent metastatic melanoma. The results of the trial will be used to support registration of…
ID
Source
Brief title
Condition
- Skin neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To compare the overall response rate at *24 weeks after randomization in the
Allovectin-7® arm versus the control (DTIC/TMZ) arm.
Secondary outcome
First, to investigate the effect of Allovectin-7® in comparison to DTIC/ TMZ on
overall survival. Second: To investigate the safety/tolerability of
Allovectin-7® in comparison to DTIC/TMZ.
Background summary
The outlook for patients with advanced metastatic melanoma remains poor.
Median survival ranges from 6*10 months, with few long-term survivors.
Currently in the US, two single-agent products are indicated for first-line
non-surgical treatment of metastatic melanoma: DTIC-Dome® (dacarbazine) and
Proleukin® (aldesleukin). Both therapies are limited by high toxicity. An
alternative therapy whereby efficacy and safety synchronize to provide the
melanoma subject a palliative treatment is warranted.
Study objective
The objective of the trial is to compare the efficacy and safety of treatment
with Allovectin 7® versus treatment with DTIC or TMZ in subjects with recurrent
metastatic melanoma. The results of the trial will be used to support
registration of Allovectin 7® for marketing in the U.S., and may eventually be
used to support marketing applications in the EU as well.
Study design
Phase 3, randomized (2:1), controlled, open-label, multi-center trial
Intervention
Treatment Arm: Allovectin-7® 2 mg intralesional injection into a single lesion
weekly for six consecutive weeks, repeated beginning after each 8th week.
Control Arm: DTIC 1000 mg/m2 intravenous infusion over 60 minutes, repeated
every 28 days Or TMZ 150 to 200 mg/m2 orally once daily for five consecutive
days, repeated every 28 days.
Formal and complete disease assessments at pre-trial, Week 16, and at the end
of every eight weeks for up to twelve months, then every twelve weeks for the
second year, and for confirmation. If there is no protocol defined Progressive
Disease (PD) and further treatment is likely to be tolerated, subjects will be
encouraged to continue to the next cycle of treatment. An assessment for
clinical progression or a need for Palliative Care will occur at Week 8.
Study burden and risks
Allovectin-7® has been given to over 700 subjects. Most side effects have been
mild or moderate and the majority were due to pain or inflammation at the
injection site. Other mild or moderate side effects have been chills, fatigue,
nausea, general body aches, vitiligo (patchy loss of skin color), and fever.
There may not be any benefit for patients participating in the study.
Participation in this study may help cause remission of the disease and improve
symptoms.
10390 Pacific Center Court
San Diego, CA 92121
US
10390 Pacific Center Court
San Diego, CA 92121
US
Listed location countries
Age
Inclusion criteria
* Histologically confirmed recurrent metastatic melanoma, which may have received primary surgical resection, adjuvant therapy, and/or biotherapy
* At least one injectable lesion (cutaneous, subcutaneous, or nodal lesion) *1 cm2 and * 25 cm2
* Normal LDH
* ECOG performance status of 0 or 1
Exclusion criteria
* Surgery is deemed a curative option
* Prior cytotoxic chemotherapy
* Any lesion *100 cm2
* History of visceral metastasis, M1c, other than lung (M1b not excluded)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-004120-21-NL |
| ClinicalTrials.gov | NCT00395070 |
| CCMO | NL21254.000.08 |