RAV12 in Treating Patients With Metastatic or Recurrent Adenocarcinoma (NCT00101972) | Clinical Trial Compass
CompletedPhase 1
RAV12 in Treating Patients With Metastatic or Recurrent Adenocarcinoma
United States53 participantsStarted 2004-12
Plain-language summary
RATIONALE: Monoclonal antibodies, such as RAV12, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase I trial is studying the side effects and best dose of RAV12 in treating patients with metastatic or recurrent adenocarcinoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma
* Metastatic or recurrent disease
* Not curable by standard therapies
* Must have failed at least 1, but no more than 3, prior therapies for metastatic or recurrent disease
* Patients with colorectal or breast adenocarcinoma must have failed at least 2 prior therapies
* Must have had at least stable disease for 3 months while on last treatment prior to most recent disease progression
* Meets 1 of the following criteria:
* At least 1 measurable site of disease ≥ 2 cm by radiography
* Evaluable disease that could be reliably and consistently followed, as deemed by the principal investigator
* RAAG12 expression confirmed\* by immunohistochemistry NOTE: \*Not required for patients with colon, pancreatic, or gastric adenocarcinoma
* No evidence of residual or recurrent CNS metastases
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Not specified
Menopausal status
* Not specified
Performance status
* ECOG 0-1
Life expectancy
* More than 3 months
Hematopoietic
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL (transfusions allowed)
* Absolute neutrophil count ≥ 1,500/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
* γ-glutamyl transferase ≤ 2.5 times ULN
* Adequate hepatic function sufficient to undergo study therapy
Renal
* Creatinine \< 1.5 mg/d…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.