Testicular CancerPhase 2NCT00936936
High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors
A Phase 2 study testing Gemcitabine, Docetaxel and Melphalan in people with Testicular Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
The goal of this clinical research study is to learn if 2 cycles of high-dose chemotherapy can help to control germ-cell tumors. The first cycle of chemotherapy will include the drugs gemcitabine, docetaxel, melphalan, and carboplatin. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Testicular Cancer
- What is being tested?
- Gemcitabine, Docetaxel and Melphalan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jun 2009to 11 Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female patients, age 12 to 65 years.
- Patients with seminomatous or nonseminomatous germ-cell tumors (GCT) in one of the following groups: A) First relapse or progression or second response with an intermediate or high risk according to the Beyer model. B) Second relapse or beyond.
- Adequate renal glomerular and tubular function, as defined by estimated serum creatinine clearance >/=50 ml/min and/or serum creatinine </= 1.8 mg/dL, and urinary protein excretion </=500 mg/day.
- Adequate hepatic function, as defined by ALT and AST </=3 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase </=2 x ULN or considered not clinically significant.
- Adequate pulmonary function with FEV1 (Forced expiratory volume in the first second), FVC (Forced vital capacity) and DLCO (diffusing capacity of the lung for carbon monoxide) >/=50% of predicted, corrected for volume and hemoglobin.
- Adequate cardiac function with LVEF (left ventricular ejection fraction) >/=40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
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- Zubrod performance status 0-2.
- A minimum apheresis collection of 5 million CD34+ cells/kg of autologous hematopoietic progenitor cells (AHPC).
- Written informed consent by patients and/ or their parents or legal guardians. Assent for those patients inclusive of ages 12 to 17.
Who cannot join
- Growing teratoma syndrome, defined as enlarging tumor masses with normal serum markers during chemotherapy for nonseminomatous GCT.
- Major surgery within 30 days before the initiation of study treatment
- Radiotherapy within 21 days prior to initiation of study treatment
- Prior whole brain irradiation.
- Patients with active central nervous system (CNS) disease, defined as brain or meningeal metastases that are not in complete remission.
- Patients with active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA >/=10,000 copies/mL, or >/= 2,000 IU/mL).
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- Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients who either show chronic hepatitis C or positive hepatitis C serology.
- Active infection requiring parenteral antibiotics.
- HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal CD4 counts
- Patients who have had a previous autologous or allogeneic stem cell transplant in the previous 12 months.
- Positive pregnancy test in a female patient of childbearing potential defined as not post menopausal for twelve months or no previous surgical sterilization.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas MD Anderson Cancer Center
Houston, Texas, 77007
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
About this study
The goal of this clinical research study is to learn if 2 cycles of high-dose chemotherapy can help to control germ-cell tumors. The first cycle of chemotherapy will include the drugs gemcitabine, docetaxel, melphalan, and carboplatin. The second cycle of chemotherapy will include the drugs ifosfamide, carboplatin, and etoposide. The safety of these drug combinations will also be studied.
This is an investigational study. Gemcitabine, docetaxel, melphalan, ifosfamide, carboplatin, and etoposide are all FDA-approved and commercially available for the treatment of germ-cell tumors.
Up to 67 patients will be enrolled in this study.
Read the detailed description
The Study Drugs:
Carboplatin, melphalan, and ifosfamide are designed to damage the DNA (the genetic material) of cancer cells, which may cause the cancer cells to die.
Docetaxel and etoposide are designed to stop the growth of cancer cells, which may cause the cancer cells to die.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die. It may also help docetaxel, carboplatin, and melphalan to be more effective by stopping tumor cells from repairing damage caused by these drugs.
Study Drug Administration:
You will receive 2 cycles of high-dose chemotherapy with stem-cell support, 1-2 months apart.
You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg.
Starting on the first day of your hospital stay, you will begin gargling and swishing Caphosol and Glutamine in your mouth 4 times a day. This is done to help prevent mouth and throat sores.
On Day 2 of your stay in the hospital, through the CVC, you will receive gemcitabine over 4 hours and docetaxel over 2 hours.
On Days 3-5, through the CVC, you will receive gemcitabine over 4 hours, melphalan over 15 minutes, and carboplatin over 2 hours.
On Day 6, you will not receive any study drugs.
On Day 7, you will receive the stem cells through the CVC over about 30-60 minutes.
As part of standard care, you will receive G-CSF (filgrastim) as an injection under your skin daily, starting 5 days after the transplant, until your blood cell levels return to normal.
As part of standard mouth care you will be asked to do mouthwashes 4 times a day with caphosol (artificial saliva) and glutamine.
Two (2) to 4 weeks after you leave the hospital after Cycle 1, you will receive your second cycle of high-dose chemotherapy.
On Days 2-4 of your stay in the hospital, through the CVC, you will receive ifosfamide over 6 hours, etoposide over 2 hours, and carboplatin over 2 hours.
On Days 5-6, you will not receive any study drugs.
On Day 7, you will receive the stem cells through the CVC over about 30-60 minutes.
Study Visits:
About 1 month, 100 days, 6 months and 1 year after your second stem cell transplant, the following tests and procedures will be performed:
- To check the status of the disease, you will have CT scans of your chest, abdomen, and pelvis.
- Blood (about 3 tablespoons) will be drawn for routine tests.
Length of Study:
You will be off study after about 1 year from your second transplant. You will be taken off study early if the disease gets worse or if you experience any intolerable side effects.
Long-Term Follow-up:
If your doctor thinks it is needed, you may have follow-up visits.
- Conditions
- Testicular Cancer
- Being tested
- Gemcitabine, Docetaxel, Melphalan, Carboplatin, Mesna
- Keywords
- Testis, Relapsed Testicular Cancer, Bevacizumab, Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF, Carboplatin, Paraplatin, Docetaxel, Taxotere, Etoposide, VePesid, Gemcitabine, Gemcitabine Hydrochloride, Gemzar, Ifosfamide, Ifex, Melphalan, Alkeran
- Medical subject headings
- Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemcitabine Hydrochloride, Gemzar
1800 mg/m^2 IV over 3 hours on Days -5 to Day -2.
DocetaxelDrug
Also called Taxotere
Docetaxel 300 mg/m^2 IV over 2 hours on Day -5.
MelphalanDrug
Also called Alkeran
50 mg/m^2 IV over 15 minutes on Days -4 to Day -2.
CarboplatinDrug
Also called Paraplatin
Cycle 1: 333 mg/m^2 IV over 2 hours on Days -4 to -2.
Cycle #2: 300 mg/m^2 IV over 2 hours on Days -6 to -3.
MesnaDrug
Also called Mesnex
3,000 mg/m^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4.
IfosfamideDrug
Also called Ifex
3,000 mg/m^2 IV over 6 hours on Days -6 to -3
EtoposideDrug
Also called VePesid
200 mg/m^2 IV over 3 hours, every 12 hours on Days -6 to -4.
Stem Cell TransplantProcedure or surgery
Also called SCT, Hematopoietic progenitor-cell infusion, PBPC
Stem cell infusion on Day 0.
| Study group | Role | What they receive |
|---|---|---|
| Cycle # 1 | Experimental | First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Receives: Drug: Gemcitabine; Drug: Docetaxel; Drug: Melphalan; Drug: Carboplatin; Procedure: Stem Cell Transplant |
| Cycle #2 | Experimental | Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC)
HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Receives: Drug: Carboplatin; Drug: Mesna; Drug: Ifosfamide; Drug: Etoposide; Procedure: Stem Cell Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With 2-year Event-Free Survival (EFS)
Event-free survival estimated from the first day of High-Dose Course Cycle #1 (Day -6) until tumor progression, relapse, or death from any cause.
Measured: 2 Years
Secondary outcomes (1)
Overall Survival
Number of Participants alive and disease free 1 year post treatment completion.
Measured: 1 year post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study start2 Jun 2009
- Primary completion11 Jan 2024
- Study completion11 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yago Nieto, MD, PHD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936936
- Sponsor's protocol ID
- 2008-0378
- Other IDs
- NCI-2011-01631
- Status last verified
- Aug 2024
- First submitted
- 8 Jul 2009
- Last updated
- 26 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Nieto Y, Tu SM, Bassett R, Jones RB, Gulbis AM, Tannir N, Kingham A, Ledesma C, Margolin K, Holmberg L, Champlin R, Pagliaro L. Bevacizumab/high-dose chemotherapy with autologous stem-cell transplant for poor-risk relapsed or refractory germ-cell tumors. Ann Oncol. 2015 Oct;26(10):2125-32. doi: 10.1093/annonc/mdv310. Epub 2015 Jul 21.
PubMed 26199392
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors
- ClinicalTrials.gov ID
- NCT00936936
- Acronym / sponsor ID
- 2008-0378
- Conditions
- Testicular Cancer
- Keywords
- Testis, Relapsed Testicular Cancer, Bevacizumab, Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF, Carboplatin, Paraplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 2 Jun 2009 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 10 Jul 2009 (estimated)
- Results
- Posted 26 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if 2 cycles of high-dose chemotherapy can help to control germ-cell tumors. The first cycle of chemotherapy will include the drugs gemcitabine, docetaxel, melphalan, and carboplatin. The second cycle of chemotherapy will include the drugs ifosfamide, carboplatin, and etoposide. The safety of these drug combinations will also be studied.
This is an investigational study. Gemcitabine, docetaxel, melphalan, ifosfamide, carboplatin, and etoposide are all FDA-approved and commercially available for the treatment of germ-cell tumors.
Up to 67 patients will be enrolled in this study.
Detailed description
The Study Drugs:
Carboplatin, melphalan, and ifosfamide are designed to damage the DNA (the genetic material) of cancer cells, which may cause the cancer cells to die.
Docetaxel and etoposide are designed to stop the growth of cancer cells, which may cause the cancer cells to die.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die. It may also help docetaxel, carboplatin, and melphalan to be more effective by stopping tumor cells from repairing damage caused by these drugs.
Study Drug Administration:
You will receive 2 cycles of high-dose chemotherapy with stem-cell support, 1-2 months apart.
You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg.
Starting on the first day of your hospital stay, you will begin gargling and swishing Caphosol and Glutamine in your mouth 4 times a day. This is done to help prevent mouth and throat sores.
On Day 2 of your stay in the hospital, through the CVC, you will receive gemcitabine over 4 hours and docetaxel over 2 hours.
On Days 3-5, through the CVC, you will receive gemcitabine over 4 hours, melphalan over 15 minutes, and carboplatin over 2 hours.
On Day 6, you will not receive any study drugs.
On Day 7, you will receive the stem cells through the CVC over about 30-60 minutes.
As part of standard care, you will receive G-CSF (filgrastim) as an injection under your skin daily, starting 5 days after the transplant, until your blood cell levels return to normal.
As part of standard mouth care you will be asked to do mouthwashes 4 times a day with caphosol (artificial saliva) and glutamine.
Two (2) to 4 weeks after you leave the hospital after Cycle 1, you will receive your second cycle of high-dose chemotherapy.
On Days 2-4 of your stay in the hospital, through the CVC, you will receive ifosfamide over 6 hours, etoposide over 2 hours, and carboplatin over 2 hours.
On Days 5-6, you will not receive any study drugs.
On Day 7, you will receive the stem cells through the CVC over about 30-60 minutes.
Study Visits:
About 1 month, 100 days, 6 months and 1 year after your second stem cell transplant, the following tests and procedures will be performed:
- To check the status of the disease, you will have CT scans of your chest, abdomen, and pelvis.
- Blood (about 3 tablespoons) will be drawn for routine tests.
Length of Study:
You will be off study after about 1 year from your second transplant. You will be taken off study early if the disease gets worse or if you experience any intolerable side effects.
Long-Term Follow-up:
If your doctor thinks it is needed, you may have follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cycle # 1 | Experimental | Drug: Gemcitabine, Drug: Docetaxel, Drug: Melphalan, Drug: Carboplatin, Procedure: Stem Cell TransplantFirst Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC |
| Cycle #2 | Experimental | Drug: Carboplatin, Drug: Mesna, Drug: Ifosfamide, Drug: Etoposide, Procedure: Stem Cell TransplantSecond Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female patients, age 12 to 65 years.
- Patients with seminomatous or nonseminomatous germ-cell tumors (GCT) in one of the following groups: A) First relapse or progression or second response with an intermediate or high risk according to the Beyer model. B) Second relapse or beyond.
- Adequate renal glomerular and tubular function, as defined by estimated serum creatinine clearance >/=50 ml/min and/or serum creatinine </= 1.8 mg/dL, and urinary protein excretion </=500 mg/day.
- Adequate hepatic function, as defined by ALT and AST </=3 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase </=2 x ULN or considered not clinically significant.
- Adequate pulmonary function with FEV1 (Forced expiratory volume in the first second), FVC (Forced vital capacity) and DLCO (diffusing capacity of the lung for carbon monoxide) >/=50% of predicted, corrected for volume and hemoglobin.
Key exclusion criteria (11 listed)
- Growing teratoma syndrome, defined as enlarging tumor masses with normal serum markers during chemotherapy for nonseminomatous GCT.
- Major surgery within 30 days before the initiation of study treatment
- Radiotherapy within 21 days prior to initiation of study treatment
- Prior whole brain irradiation.
- Patients with active central nervous system (CNS) disease, defined as brain or meningeal metastases that are not in complete remission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GemcitabineAlso: Gemcitabine Hydrochloride, Gemzar1800 mg/m^2 IV over 3 hours on Days -5 to Day -2. | Drug | Cycle # 1 |
| DocetaxelAlso: TaxotereDocetaxel 300 mg/m^2 IV over 2 hours on Day -5. | Drug | Cycle # 1 |
| MelphalanAlso: Alkeran50 mg/m^2 IV over 15 minutes on Days -4 to Day -2. | Drug | Cycle # 1 |
| CarboplatinAlso: ParaplatinCycle 1: 333 mg/m^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m^2 IV over 2 hours on Days -6 to -3. | Drug | Cycle # 1, Cycle #2 |
| MesnaAlso: Mesnex3,000 mg/m^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. | Drug | Cycle #2 |
| IfosfamideAlso: Ifex3,000 mg/m^2 IV over 6 hours on Days -6 to -3 | Drug | Cycle #2 |
| EtoposideAlso: VePesid200 mg/m^2 IV over 3 hours, every 12 hours on Days -6 to -4. | Drug | Cycle #2 |
| Stem Cell TransplantAlso: SCT, Hematopoietic progenitor-cell infusion, PBPCStem cell infusion on Day 0. | Procedure or surgery | Cycle # 1, Cycle #2 |
Primary outcome
Number of Participants With 2-year Event-Free Survival (EFS)
Time frame: 2 Years
Event-free survival estimated from the first day of High-Dose Course Cycle #1 (Day -6) until tumor progression, relapse, or death from any cause.
1 secondary outcome
Overall Survival
Time frame: 1 year post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26199392Nieto Y, Tu SM, Bassett R, Jones RB, Gulbis AM, Tannir N, Kingham A, Ledesma C, Margolin K, Holmberg L, Champlin R, Pagliaro L. Bevacizumab/high-dose chemotherapy with autologous stem-cell transplant for poor-risk relapsed or refractory germ-cell tumors. Ann Oncol. 2015 Oct;26(10):2125-32. doi: 10.1093/annonc/mdv310. Epub 2015 Jul 21.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yago Nieto, MD, PHD study chair
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Docetaxel and Melphalan in people with Testicular Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With 2-year Event-Free Survival (EFS) (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00936936, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.