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Alkylating agents
Chemotherapy + Stem Cell Transplant for Solid Cancers
Phase 1
Waitlist Available
Led By Anna Pawlowska, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying a combination of drugs as a possible treatment for patients with solid tumors.
Who is the study for?
This trial is for patients with certain solid tumors like neuroblastoma or sarcomas, who've responded to previous treatments. They must have good heart, lung, liver, and kidney function and not be at high risk from the treatment. Pregnant women or those not using birth control are excluded, as are HIV patients and anyone previously treated with similar intense therapy.
What is being tested?
The study tests a combination of chemotherapy drugs (busulfan, melphalan, topotecan hydrochloride) followed by a stem cell transplant in patients with new or returning solid tumors. It aims to see how well this approach works after initial tumor shrinkage from other treatments.
What are the potential side effects?
Potential side effects include damage to bone marrow leading to low blood counts; mouth sores; nausea; vomiting; diarrhea; hair loss; liver problems such as increased enzymes and bilirubin levels; lung complications like difficulty breathing or reduced oxygen levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm IExperimental Treatment8 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
melphalan
1994
Completed Phase 3
~3530
filgrastim
1997
Completed Phase 3
~7260
autologous bone marrow transplantation
1997
Completed Phase 3
~3880
busulfan
1999
Completed Phase 3
~3630
autologous hematopoietic stem cell transplantation
2003
Completed Phase 3
~1990
topotecan hydrochloride
1996
Completed Phase 3
~2090
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,555 Total Patients Enrolled
Anna Pawlowska, MDPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have HIV.Adults need to have good lung function, and for children, a certain measure of lung function needs to be met.You need to wait at least 2 weeks after your last treatment before joining the study.You have certain types of cancer and have responded well to chemotherapy, surgery, or radiotherapy.Your kidneys work well enough, as shown by a test measuring how well they filter waste from your blood.Your heart is strong and pumps blood well, as shown by a certain test called echocardiogram or MUGA.Your liver is working well, as shown by specific blood test results for bilirubin, SGOT, and SGPT.Your blood test shows that your platelet count is higher than 50,000/ul and your granulocyte count is at least 750 ul.If you had treatment before, it should have tried to make your condition better. If you had surgery, chemotherapy, or radiation before, it should not have included your lungs. You should only be considered if your primary site shows a complete response or partial response to the treatment.Your diagnosis has been confirmed by a pathology department, and if the cancer has come back or spread, it needs to be confirmed again by a pathologist, except for certain brain tumors and neuroblastoma.You have confirmed cancer spread to the bone marrow within 30 days of starting the treatment. If the cancer has mostly cleared from the bone marrow, you may still be eligible.You have trouble with daily activities and tasks because of your health condition.Children with certain types of advanced solid tumors who have responded at least partially to initial treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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