CLINICAL TRIAL

Stem Cell Transplant for Germ Cell Cancer

1 Prior Treatment
High Risk
Relapsed
Waitlist Available · Any Age · All Sexes · Houston, TX

This study is evaluating whether 2 cycles of chemotherapy can help to control germ-cell tumors.

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About the trial for Germ Cell Cancer

Eligible Conditions
Testicular Cancer · Testicular Neoplasms · Neoplasms, Germ Cell and Embryonal

Treatment Groups

This trial involves 2 different treatments. Stem Cell Transplant is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Stem Cell Transplant
PROCEDURE
+
Docetaxel
DRUG
+
Gemcitabine
DRUG
+
Melphalan
DRUG
+
Carboplatin
DRUG
Experimental Group 2
Ifosfamide
DRUG
+
Stem Cell Transplant
PROCEDURE
+
Etoposide
DRUG
+
Carboplatin
DRUG
+
Mesna
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ifosfamide
FDA approved
Stem Cell Transplant
2007
Completed Phase 3
~1420
Docetaxel
FDA approved
Gemcitabine
FDA approved
Melphalan
FDA approved
Etoposide
FDA approved
Carboplatin
FDA approved
Coenzyme M
FDA approved

Eligibility

This trial is for patients born any sex of any age. You must have received 1 prior treatment for Germ Cell Cancer or one of the other 2 conditions listed above. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
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 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.
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.
Male or female patients, age 12 to 65 years.
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.
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.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 Years
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 Years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 Years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Stem Cell Transplant will improve 1 primary outcome in patients with Germ Cell Cancer. Measurement will happen over the course of 2 Years.

2-year Event-Free Survival (EFS)
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.
2 YEARS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes germ cell cancer?

Germ cell tumor development can be affected by abnormal gene mutations and environmental exposures. The risk of developing germ cell cancer is highest in males living in countries with high rates of ambient radiation.

Anonymous Patient Answer

How many people get germ cell cancer a year in the United States?

[Germ cell cancer is a very rare form of cancer that affects 1 out of 200,000 people a year in the USA.] [In the past, germ cell cancer could have taken much longer to diagnose, but over the past 10 years, advances that have made this the most curable form of cancer have made it possible to detect and treat the disease at an earlier stage and with a higher survival rate.] [Unfortunately, current prevention strategies are not as effective as some of the treatments available. At this time, the only option for prevention is the removal of the testicles from men after either testis-sparing surgery or radiation therapy for early germ cell cancer.

Anonymous Patient Answer

What are common treatments for germ cell cancer?

Treatment for germ cell cancers can vary widely depending on the specific type and stage of cancer, which is often determined by the type of stem cells present in the body. In addition to surgery, the doctors' treatments often have a big effect on the cure rate from a germ cell cancer. The treatment for testicular and ovarian germ cell cancer is similar since it takes place on the same body part. Germ cell cancers that are treated before puberty are more likely to have an 80% cure rate and less than 5% relapse rate. Germ cell cancers that are treated after puberty are very likely to have a relapse rate of 6% to 10%, and a large percentage have an 80% to 90% cure rate.

Anonymous Patient Answer

What are the signs of germ cell cancer?

The signs of germ cell cancer typically present as acute or chronic gonadal symptoms. These symptoms are most likely to be seen in adolescents and young men. The underlying causes of testis and ovodynera tumors are not apparent and are thus termed 'idiopathic' testis tumors. All patients with signs and symptoms of germ cell tumor are treated with gonadotrophin stimulation. The use of progesterone in patients with no ovarian function and signs of germ cell tumor requires further investigation.

Anonymous Patient Answer

What is germ cell cancer?

Germ cell cancers are all cancers that arise from or are composed of, or that result from the cells that give rise to, gametes and germ cells, i.e. sperm and egg cells in males; and ovum and ova cells in females. Germ cell cancers include all benign and malignant cancers of the sex organs. They are the most common cancers in childhood. Germ cell cancers are grouped into three main types: seminomatous, non-seminomatous, and yolk sac tumors. The most common type of germ cell tumors are seminomas, in males. Osteoblastic (that is, cancer of the bone marrow that produces blood cells).

Anonymous Patient Answer

Can germ cell cancer be cured?

This paper contains the first paper to be published on the possibility of cure of germ cell cancer. Recent findings of this paper suggest that, although germ cell cancer may be curable and not fatal, this treatment may not be as effective as for solid cancers.

Anonymous Patient Answer

Is stem cell transplant typically used in combination with any other treatments?

Stem cell therapies are a potent treatment for patients with multiple myeloma and non-Hodgkin's lymphoma. Patients must be informed of the possible impact that stem cell transplants can have on their other treatments to help maintain quality of life.

Anonymous Patient Answer

What is the latest research for germ cell cancer?

Germ cell tumors (GCT) are the most common malignancy of the testis. This can be attributable to immunosuppression, or it is a reflection of the increasing number of infants with tumors of this type. This article will discuss recent research for GCT. These include studies of a new immunotherapy drug, [ribotoxumab mertansine], and [gerbacurumab] anti-CD22 antibody, [inotuzumab velotuzumab] anti-B7-H2 tumor antigen, and [totransformation] anti-GM1 antibody, [anti-epithelial membrane protein 2 antibody].

Anonymous Patient Answer

What is stem cell transplant?

stem cell transplant is more advanced than most people suspect; they can transplanted as a treatment strategy against cancer that is currently progressing, or that may progress into more advanced forms of disease. Stem cell transplantation in conjunction with standard care as an effective cancer treatment strategy is feasible in pediatric patients.

Anonymous Patient Answer

What does stem cell transplant usually treat?

Although there are numerous conditions treated by stem cell transplant for cancer, the main reason is to treat blood and immune disorders. Stem cell transplant is also important for [multiple myeloma](https://www.withpower.com/clinical-trials/multiple-myeloma) because a low number of mature circulating myeloma fragments can be very small, making complete remission and long-term disease-free survival almost impossible in myeloma. The main advantage of stem cell transplant is to cure the patient with cancer and to give them a chance for a good life afterwards for health, even if the patient will die from another condition later on.

Anonymous Patient Answer

What are the common side effects of stem cell transplant?

Recent findings showed that patients who received autologous BMT showed a higher rate of severe adverse events in comparison with those who received allogeneic BMT. Other major complications of autologous BMT, i.e. hemorrhagic transformation and graft-vs.-host disease, were not recorded. Most of the adverse reactions that occurred were reversible. Therefore, more efficient and better-tolerated conditioning regimen and more frequent follow-up care should be required for patients after autologous BMT.

Anonymous Patient Answer

What are the chances of developing germ cell cancer?

The present study provides important information for the counselling of germ cell tumour patients and the public about the risks of germ cell tumour development. The risks must be clearly and objectively communicated.

Anonymous Patient Answer
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